December 22, 2021

Biolase Inc.
Ed Balcos
Manager, Regulatory Affairs
27042 Towne Centre Drive, Suite 270
Foothill Ranch, California 92610

Re: K213428
Trade/Device Name: EdgePro
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In
Dermatology
Regulatory Class: Class II
Product Code: NVK, GEX
Dated: November 4, 2021
Received: November 22, 2021

Dear Ed Balcos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.30
Silver Spring, MD 20993
www.fda.gov
K213428 - Ed Balcos Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE.
Assistant Director
DHT1B: Division of Dental and
ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

51O(k) Number (if known)

K213428
Device Name
EdgePro

Indications for Use (Describe)

Root Canal Hard Tissue Indications (for use on adult and pediatric patients)
- Root canal preparation including enlargement
- Root canal debridement and cleaning

Root Canal Disinfection (for use on adult and pediatric patients)

- Laser root canal disinfection after endodontic treatment

Type of Use (Select one or both, as applicable)

IZJ Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid 0MB number."

FORM FDA 3881 (6120) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DOb-l
 510(k) SUMMARY - K213428

I. SUBMITTER

Biolase, Inc
27042 Towne Centre Drive, Suite 270
Foothill Ranch, CA 92610 USA
Tel: (949) 226-8119
Fax: (949) 273-6677
Contact Person: Ed Balcos
Email: ebalcos@biolase.com
Date Prepared: October 18, 2021

II. DEVICE
Name of Device: EdgePro
Common Name: Er,Cr:YSGG Laser
Classification Name: Laser surgical instrument for use in general and plastic surgery
and in dermatology (21 CFR 878.4810)
Device Class: II
Product Code: NVK, GEX

III. PREDICATE DEVICE

Waterlase Express, Biolase, Inc., K161669 (Primary Predicate)

IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION EdgePro

is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr:YSGG)solid-state laser
that provides optical energy to the user-controlled distribution of atomized water droplets at
2780 nm. The laser system consists of a top-table console which houses
the laser head, power supply, cooling system, micro-processor and a removable tablet PC as
a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy
to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from
the Handpiece head illuminates the area. The laser is activated by means of a wireless
footswitch. Various laser tips are available for different clinical applications.
EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour,
roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for
cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and
coagulation as well as specific endodontic and periodontal applications.

Biolase, Inc.
EdgePro – Special 510(k) Submission

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 V. INDICATIONS FOR USE
The EdgePro indications for use are as follows:
Root Canal Hard Tissue Indications (for use on adult and pediatric patients)
• Root canal preparation including enlargement
• Root canal debridement and cleaning

Root Canal Disinfection (for use on adult and pediatric patients)

• Laser root canal disinfection after endodontic treatment

Biolase, Inc.
EdgePro – Special 510(k) Submission

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 VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
DEVICE
The EdgePro subject device and the Waterlase Express predicate device are based on the
same technological principlesincluding:

• Solid-state Er, Cr;YSGG laser at 2780nm wavelength

• Laser is running at a free-running mode without any additional light modulation features
• Output radiation is pulsed and can be controlled in multiple ways: energy per
pulse,pulse duration and pulse repetitionrate
• System contains air/water supply that allows controlled delivery of very precisewater
particles to the treatment site
• System is PEMS, programmable embedded medical system

Detailed Description of Changes Made

EdgePro is based on the previously cleared Waterlase Express device (K161669), but limited to
previously cleared indications for use;
- Root Canal Hard Tissue Indications
• Root canal preparation including enlargement and
• Root canal debridement and cleaning
- Root Canal Disinfection
• Laser root canal disinfection after endodontic treatment

EdgePro has changes made to the cosmetic exterior housing and integrated
interface/control panel configured to be focused on the limited root canal indications as
previously stated.

Summary of technological characteristics between the subject and predicate device is

presented in Table 1, below.

Biolase, Inc.
EdgePro – Special 510(k) Submission

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 Table 1: Comparison of EdgePro to Waterlase Express

Subject Device Predicate Device

(K213428) (K161669)
Comparison

Device Name EdgePro Waterlase Express

Product Code GEX GEX No Change

Application Dental Dental No Change

Laser Medium Er, Cr: YSGG Er, Cr: YSGG No Change

Laser Classification IV(4) IV(4) No Change

Wavelength 2780 nm 2780 nm No Change

Max power of 2W is sufficient for
Max Power Output Up to 4 W effective root canal indications
Up to 2 W Therefore, substantially equivalent.

Output Mode Pulsed Pulsed No Change

Lower max pulse energy, is sufficient
for effective root canal indications
Max Pulse Energy 200 mJ
100mJ Therefore, substantially equivalent.

10–170 J/cm2 No Change

Fluence per Spot 10–170 J/cm2

Repetition Rate No Change

5-50 Hz
(Frequency) 5-50 Hz

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 Convenience only; therefore,
Spot Size 200 – 500 µm 200 – 1,200 µm substantially equivalent.

Eliminated Soft Mode, Hard model is

sufficient for effective root canal
Pulse Duration
60 µs 60 µs, 700 µs indications
(Width)
Therefore, substantially equivalent.

Diode laser, max 3 mW, Diode laser, max 3 mW,

Aiming Beam 625-670 nm No Change
625-670 nm
Operating Voltage 100 / 230 VAC 100 / 230 VAC No Change
User Interface / Convenience only; therefore,
Tablet PC
Control Panel Integrated Display substantially equivalent.
Footswitch Wireless / Wired No Change
Wireless / Wired

Labeling IFU IFU Limited to Root Canal Indications;

therefore, substantially equivalent.
Medical grade plastic, stainless steel, Medical grade plastic, stainless
aluminum, brass, and electronic parts steel, aluminum, brass, and No Change
Materials
and components electronic parts and components

Biolase, Inc.
EdgePro – Special 510(k) Submission

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 Subject Device Predicate Device Comparison

General Hard Tissue Indications (for use in adult and Limited to Root Canal
pediatric patients) Indications; therefore,
• Class I, II, III, IV and V cavity preparation substantially equivalent.
• Caries removal
• Hard tissue surface roughening or etching
• Enameloplasty, excavation of pits and fissures for
placement of sealants

Root Canal Hard Tissue Indications

Root Canal Hard Tissue • Root canal preparation including enlargement
Indications • Root canal debridement and cleaning
• Root canal preparation including
Indications for enlargement Root Canal Disinfection
Use • Root canal debridement and • Laser root canal disinfection after endodontic treatment
cleaning

Root Canal Disinfection Endodontic Surgery (Root Amputation) Indications

• Laser root canal disinfection after • Flap preparation – incision of soft tissue to prepare a flap
endodontic treatment and expose the bon
• Cutting bone to prepare a window access to the apex
(apices) of the root(s)

• Apicoectomy – amputation of the root end

• Root end preparation for retrofill amalgam or composite
• Removal of pathological tissues (i.e., cysts, neoplasm or
abscess) and hyperplastic tissues (i.e., granulation tissue)
from around the apex

Biolase, Inc.
EdgePro – Special 510(k) Submission

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 NOTE: Any tissue growth (i.e., cyst, neoplasm or other
lesions) must be submitted to a qualified laboratory for
histopathological evaluation.

Bone Surgical Indications

• Cutting, shaving, contouring and resection of oral osseous
tissues (bone)
• Osteotomy

Soft Tissue Indications including Pulpal Tissues (for use

on adult and pediatric patient)
Incision, excision, vaporization, ablation and coagulation of
oral soft tissues including:
• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Flap preparation – incision of soft tissue to prepare a flap
and expose the bone
• Flap preparation – incision of soft tissue to prepare a flap
and expose unerupted teeth (hard and soft tissue
impactions)
• Frenectomy and frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscesses
• Laser soft tissue curettage of the post-extraction tooth
sockets and the periapical area during apical surgery
• Leukoplakia
Biolase, Inc.
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 • Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Reduction of gingival hypertrophy
• Soft tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of
the oral mucosa
• Vestibuloplasty
• Removal of pathological tissues (i.e., cysts, neoplasm or
abscess) and hyperplastic tissues (i.e., granulation tissue)
from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other
lesions) must be
submitted to a qualified laboratory for histopathological
evaluation

Laser Periodontal Procedures

• Full thickness flap
• Partial thickness flap
• Split thickness flap
• Laser soft tissue curettage
• Laser removal of diseased, infected, inflamed and
necrosed soft tissue within the periodontal pocket
• Removal of highly inflamed edematous tissue affected by
bacteria penetration of the pocket lining junctional
epithelium
• Removal of granulation tissue from bony defects
• Sulcular debridement (removal of diseased, infected,
inflamed or necrosed soft tissue in the periodontal pocket
Biolase, Inc.
EdgePro – Special 510(k) Submission

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 to improve clinical indices including gingival index,
gingival bleeding index, probe depth, attachment loss and
tooth mobility)
• Osteoplasty and osseous recontouring (removal of bone to
correct osseous defects and create physiologic osseous
contours)
• Ostectomy (resection of bone to restore bony architecture,
resection of bone for grafting, etc.)
• Osseous crown lengthening
• Removal of subgingival calculi in periodontal pockets
with
periodontitis by closed or open curettage
• Waterlase Er,Cr:YSGG assisted new attachment procedure
(cementum-mediated periodontal ligament new-
attachment to the root surface in the absence of long
junctional epithelium.
Other changes
to labeling or
design since
No Change No Change No Change
the most
recently
cleared 510(k)

Biolase, Inc.
EdgePro – Special 510(k) Submission

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 VII. PERFORMANCE DATA
The following performance data were provided in support of substantial equivalence
determination:

Biocompatibility Testing
Biocompatibility was not performed for the subject device since the materials
as same from the predicate device and theperformance characteristics are
equivalent.
Biocompatibility performed for the predicate device evaluation was conducted
in accordance with ISO 10993-1 Biological Evaluation of Medical Devices-
Part 1: Evaluation and Testing within a Risk Management Process, as
recognized by the FDA.The battery of testing included cytotoxicity,
sensitization, intracutaneous reactivity and systemic toxicity. The results
demonstrate biocompatibility of the device.

Electrical Safety and Electromagnetic Compatibility (EMC)

Safety testing of EdgePro was conducted according to recognized
standards: IEC 60601-1-2 standard for EMC and IEC60601-1, IEC
60601-2-22, IEC 60825-1 and IEC 80601-2-60 for safety.
The device meets applicable requirements related to the above-referenced standards.

Software Verification and Validation

Software verification and validation testing was performed and
documentation was provided as recommended by FDA’sGuidance for
Industry and FDA Staff “Guidance for the Content of Premarket
Submission for Software Contained in Medical Devices and “Guidance
for the Content of Premarket Submission for Management of
Cybersecurity in Medical Devices”. The results demonstrate that
EdgePro performs according to specifications and functions intended.

Bench Testing
Testing was conducted to evaluate performance between the subject device
and predicate device. The results demonstrate that EdgePro performs as well
as the predicate device, Waterlase Express.

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EdgePro – Special 510(k) Submission

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 Clinical Testing
Clinical testing was not performed for the subject device since the
indications for use are a subset of the predicate device andthe performance
characteristics are equivalent.

VIII. CONCLUSION

EdgePro is substantially equivalent to its legally marketed predicate device,

Waterlase Express, in technical characteristics, operating principle and mechanismof
action. It has the same indications for use and equivalent performance. Therefore,
it can be concluded that EdgePro is as safe and effective as the predicate device.

Biolase, Inc.
EdgePro – Special 510(k) Submission

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