Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser device for surgical and therapeutic procedures, whitening, and pain therapy. There is no mention of AI or ML in the device description, intended use, or performance studies. The device operates based on emitting laser energy via a fiber optic cable.

Therapeutic

Yes
The device description explicitly states, "The Epic 980 diode laser is a surgical and therapeutic device..." and its intended uses include "Pain Therapy" for temporary relief of minor muscle/joint pain, which is a therapeutic application.

Diagnostic

No

The device description and intended uses clearly state that the device is a "surgical and therapeutic device" used for incising, excising, ablating, and other treatment procedures, as well as for pain relief and whitening. There is no mention of it being used to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a hardware device (diode laser) with a base console, footswitch, fiber optic cable, handpiece, and disposable tips. It emits infrared laser energy for surgical and therapeutic procedures.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Epic 980 diode laser is a surgical and therapeutic device that directly interacts with the patient's body (oral soft tissues, teeth, muscles, joints) using laser energy. It performs procedures like cutting, vaporizing, whitening, and providing pain relief.
Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It applies energy to the body.

The intended uses and device description clearly indicate that this is a therapeutic and surgical device, not a diagnostic one that analyzes samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use

510(k) Number (if known)

K192430

Device Name

Epic 980

Indications for Use (Describe)

Dental Soft Tissue Indications

Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

· Excisional and incisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Frenectomy
· Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis and coagulation
· Implant recovery
· Incision and drainage of abscess
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft-tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Vestibuloplasty
· Tissue retraction for impression
1. Laser Periodontal Procedures
· Laser soft-tissue curettage
· Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket

· Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)

1. Whitening
· Light activation for bleaching materials for teeth whitening
· Laser-assisted whitening/bleaching of teeth
1. Pain Therapy

· Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Product codes (comma separated list FDA assigned to the subject device)

GEX, ILY

Device Description

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.

The Epic 980 uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.

A visible light is emitted at the same time to visually identify the treatment location. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral soft-tissues, periodontal pocket, teeth, minor muscle and joint.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Testing

Ex-vivo testing was conducted on soft tissue to compare performance of the subject device to its predicate. The results demonstrate equivalency.

Clinical Testing

Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicate is equivalent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Epic 10, K121286

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K163128, K170500

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 4, 2019

Biolase, Inc. Alicia Mszyca Director, Regulatory Affairs 4 Cromwell Irvine, California 92618

Re: K192430

Trade/Device Name: Epic 980 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: GEX, ILY Dated: November 8, 2019 Received: November 8, 2019

Dear Alicia Mszyca:

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.

1

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.

Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192430

Device Name

Epic 980

Indications for Use (Describe)

Dental Soft Tissue Indications

Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

· Excisional and incisional biopsies
· Exposure of unerupted teeth
· Fibroma removal
· Frenectomy
· Frenotomy
· Gingival troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Gingival incision and excision
· Hemostasis and coagulation
· Implant recovery
· Incision and drainage of abscess
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft-tissue crown lengthening
· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
· Vestibuloplasty
· Tissue retraction for impression
1. Laser Periodontal Procedures
· Laser soft-tissue curettage
· Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket

· Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility)

1. Whitening
· Light activation for bleaching materials for teeth whitening
· Laser-assisted whitening/bleaching of teeth
1. Pain Therapy

· Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

3

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

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

I. SUBMITTER

Biolase, Inc. 4 Cromwell Irvine, CA 92618 USA Tel: (949) 226-8471 Fax: (949) 273-6688 Contact Person: Alicia Mszyca Date Prepared: August 30, 2019

II. DEVICE

Name of Device:	Epic 980
Common Name:	Dental Diode 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:	GEX, ILY

III. PREDICATE DEVICE

Epic 10, K121286 Epic Pro, K163128 (reference device) SIROLaser Advance +, K170500 (reference device)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION IV.

The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.

The Epic 980 uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.

A visible light is emitted at the same time to visually identify the treatment location. The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.

5

INDICATIONS FOR USE V.

Epic 980 is indicated for

1. Dental soft tissue indications

Incision, excision, vaporization, ablation, and coagulation of oral soft tissue including marginal and inter-dental gingiva and epithelial lining of free gingiva and the following specific indications:

Excisional and incisional biopsies o
Exposure of unerupted teeth O
Fibroma removal O
Frenectomy O
Frenotomy O
Gingival troughing for crown impressions O
O Gingivectomy
Gingivoplasty O
Gingival incision and excision O
Hemostasis and coagulation O
Implant recovery O
Incisions and draining of abscesses O
Leukoplakia O
Operculectomy. O
Oral papillectomies O
O Pulpotomy
Pulpotomy as an adjunct to root canal therapy O
Reduction of gingival hypertrophy O
Soft tissue crown lengthening O
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa O
Vestibuloplasty O
O Tissue retraction for impressions

2. Laser Periodontal Procedures

Laser soft tissue curettage O
Laser removal of diseased, inflamed and necrosed soft tissue within the O periodontal packet
sulcular debridement (removal of diseased or inflamed soft tissue in the о periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

3. Whitening

Laser activation for bleaching materials for teeth whitening o
о Laser assisted whitening /bleaching of teeth

4. Pain Relief

Topical heating for the purpose of elevating tissue temperature for a temporary O relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscle back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

6

SUMMARY OF SIMILARITIES AND DIFFERENCES VI.

The Epic 980 diode laser is identical to the Epic 10 predicate device except for the diode laser module. The 940nm module used in the Epic 10 is replaced with a 980nm module in the Epic 980. The diode is a component from the same diode family with equivalent operating characteristic that does not impact product safety and efficacy.

In addition, two other reference devices were identified to further support the submission. The devices are SIROLaser Advance + (K170500) manufactured by Dentsply Sirona and Epic Pro (K163128) manufactured by Biolase, Inc.

Both generate infrared laser energy via a solid-state diode laser, operate in a similar manner and have been legally marketed for the same intended use and indications for use as the Epic 980.

Detailed comparison of the intended use. indications for use and design of the Epic 980. and the predicate devices is presented in tables below.

	Subject Device	Primary Predicate	Reference Devices
Specification	Biolase Inc.
Epic 980	Biolase Inc.
Epic 10
(K121286)	Biolase Inc.
Epic Pro
(K163128)	Dentsply Sirona
SIROLaser Advance +
(K170500)
Laser source	Diode (InGaAs)	Diode (InGaAs)	Diode	Diode
Wavelength	$980 \pm 10 nm$	$940 \pm 10 nm$	$980 nm \pm 20 nm$	$970 nm$
$(-10 /+ 15nm)$
Max output
power	10 W	10 W	25W	7W
Operating
modes	Continuous,
pulse modulation	Continuous,
pulse modulation	Pulsed or continuous	Continuous, chopped
/peak pulse
Repetition Rate
(Frequency)	Up to 20 kHz	Up to 20 kHz	Up to 20 kHz	Up to 20 kHz
Pulse duration	0.01 - 20 ms	0.01 - 20 ms	50ms - 99.9s	0.01 - 0.99 s
Pulse interval
(off time
between pulses)	0.04 - 20 ms	0.04 - 20 ms	N/A	N/A
Aiming beam	diode,
max 1mW,
625 - 670 nm	diode,
max 1mW,
625 - 670 nm	diode,
max 5mW,
650nm	diode,
max 1mW,
$660 \pm 5nm$

7

Spot size
Tips
Deep Tissue HP
Whitening HP	200 – 400 μm
30mm diameter
35mm x 8mm	200 – 400 μm
30mm diameter
35mm x 8mm	300-400 μm	200,320 μm
Power density	Up to
28294W/cm2	Up to
28294W/cm2	Up to 70736W/cm2	Up to 44563W/cm2
Control panel	Touch screen	Touch screen	Touch screen	Touch screen
Footswitch	Wireless	Wireless	Wireless	Wireless
Delivery system	Fiber optic cable,
handpiece and
disposable tips	Fiber optic cable,
handpiece and
disposable tips	Fiber optic cable,
handpiece and
disposable tips	Fiber optic cable,
handpiece and
disposable tips
Fiber Tips	Quartz single-use tips varying
in length and
core diameter
(200 – 400μm)	Quartz single-use
tips varying in
length and core
diameter
(200 – 400μm)	Quartz single-use
tips varying in
length and core
diameter (300 –
400μm)	Single use tips
Materials	Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic
parts and
components	Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic
parts and
components	Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic parts
and components	Medical grade
plastics, steel,
stainless steel,
aluminum, brass,
and electronic parts
and components

Indications for use

Epic 980	Epic 10	Epic Pro	SIROLaser Advance +
(subject device)	(primary predicate)	(reference device)	(reference device)
Dental Soft Tissue
Indications
Incision, excision,
vaporization, ablation
and coagulation of oral
soft-tissues including
marginal and inter-
dental gingival and
epithelial lining of free
gingiva and the
following specific
indications:	Dental Soft Tissue
Indications
Incision, excision,
vaporization, ablation
and coagulation of oral
soft-tissues including
marginal and inter-
dental gingival and
epithelial lining of free
gingiva and the
following specific
indications:	The Epic Pro with dental
laser operation is
intended for incision,
excision, vaporization,
ablation, hemostasis, or
coagulation of intraoral
and extra-oral soft tissue
(including marginal and
interdental gingiva and
epithelial lining of free
gingiva); examples
include	Intended for intra and
extra-oral surgery
including incision,
excision, hemostasis,
coagulation and
vaporization of soft
tissue including
marginal and inter -
dental gingival and
epithelial lining of free
gingiva and is indicated
for:
excisional and incisional
biopsies	excisional and incisional
biopsies	biopsy	biopsy
exposure of unerupted
teeth	exposure of unerupted
teeth	exposure of unerupted
teeth /partially erupted
teeth;	exposure of
unerupted/partially
erupted teeth;
fibroma removal	fibroma removal	N/A	fibroma removal
frenectomy	frenectomy	frenectomy	frenectomy
frenotomy	frenotomy	frenotomy	frenotomy
gingival troughing for
crown impressions	gingival troughing for
crown impressions	gingival troughing	gingival troughing
gingivectomy	gingivectomy	gingivectomy	gingivectomy
gingivoplasty	gingivoplasty	gingivoplasty	gingivoplasty
gingival incision and
excision	gingival incision and
excision	N/A	gingival incision and
excision
hemostasis and
coagulation	hemostasis and
coagulation	hemostasis of donor site	hemostasis of donor site
implant recovery	implant recovery	implant recovery	implant recovery
incision and drainage of
abscess	incision and drainage of
abscess	incisions and draining of
abscesses;	incisions and draining
of abscesses;
leukoplakia	leukoplakia	leukoplakia	leukoplakia
operculectomy	operculectomy	operculectomy	operculectomy
oral papillectomies	oral papillectomies	papillectomy	papillectomy
pulpotomy	pulpotomy	pulpotomy	pulpotomy
pulpotomy as an adjunct
to root canal therapy	pulpotomy as an adjunct
to root canal therapy	pulpotomy as an adjunct
to root canal therapy,	pulpotomy as an
adjunct to root canal
therapy
reduction of gingival
hypertrophy	reduction of gingival
hypertrophy	N/A	reduction of gingival
hypertrophy
soft-tissue crown
lengthening	soft-tissue crown
lengthening	crown lengthening	crown lengthening
treatment of canker
sores, herpetic and
aphthous ulcers of the
oral mucosa	treatment of canker
sores, herpetic and
aphthous ulcers of the
oral mucosa	treatment of aphthous
ulcers	treatment of canker
sores, herpetic and
aphthous ulcers of the
oral mucosa
vestibuloplasty	vestibuloplasty	vestibuloplasty	vestibuloplasty
tissue retraction for	tissue retraction for	tissue retraction for	tissue retraction for
impression	impression	impressions	impression
Laser Periodontal Procedures
laser soft-tissue
curettage	laser soft-tissue
curettage	N/A	laser soft-tissue
curettage
laser removal of
diseased, infected,
inflamed and necrosed
soft-tissue within the
periodontal pocket	laser removal of
diseased, infected,
inflamed and necrosed
soft-tissue within the
periodontal pocket	N/A	laser removal of
diseased, infected,
inflamed and necrosed
soft-tissue within the
periodontal pocket
sulcular debridement
(removal of diseased,
infected, inflamed and
necrosed soft-tissue in
the periodontal pocket to
improve clinical indices
including gingival index,
gingival bleeding index,
probe depth, attachment
loss and tooth mobility)	sulcular debridement
(removal of diseased,
infected, inflamed and
necrosed soft-tissue in
the periodontal pocket to
improve clinical indices
including gingival index,
gingival bleeding index,
probe depth, attachment
loss and tooth mobility)	sulcular debridement
(removal of diseased or
inflamed soft tissue in
the periodontal pocket)	sulcular debridement
(removal of diseased,
infected, inflamed and
necrosed soft-tissue in
the periodontal pocket
to improve clinical
indices including
gingival index, gingival
bleeding index, probe
depth, attachment loss

| Whitening | | | |
| light activation for
bleaching materials for
teeth whitening | light activation for
bleaching materials for
teeth whitening | light activation of
bleaching materials for
teeth whitening. | light activation for
bleaching materials for
teeth whitening |
| laser-assisted
whitening/bleaching of
teeth | laser-assisted
whitening/bleaching of
teeth | N/A | laser-assisted
whitening/bleaching of
teeth |
| Pain Therapy (Low Level laser Therapy) | | | |
| Topical heating for the
purpose of elevating
tissue temperature for a
temporary relief of
minor muscle and joint
pain and stiffness, minor
arthritis pain, or muscle
spasm, minor sprains
and strains, and minor
muscular back pain; the
temporary increase in | Topical heating for the
purpose of elevating
tissue temperature for a
temporary relief of
minor muscle and joint
pain and stiffness, minor
arthritis pain, or muscle
spasm, minor sprains
and strains, and minor
muscular back pain; the
temporary increase in | N/A | Intended to emit energy
in the red and infrared
spectrum to provide
topical heating for the
purpose of elevating
tissue temperature for
the temporary relief of
minor muscle and joint
pain and stiffness,
minor arthritis pain, or
muscle spasm and for |
| local blood circulation;
the temporary relaxation
of muscle. | local blood circulation;
the temporary relaxation
of muscle. | the temporary increase
in local blood
circulation and/or
temporary relaxation of
muscle. | |

8

9

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VII. PERFORMANCE DATA

The following information was provided to support the submission:

Biocompatibility Testing

The biocompatibility evaluation of the modified device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process

The results demonstrate biocompatibility of the device and its accessories.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and electromagnetic compatibility testing conducted according to the current revisions of recognized standards demonstrate compliance with the standards:

IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for ● safety -electromagnetic compatibility (EMC)- requirements and tests.
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC 60601-2-22: Medical electrical equipment Part 2-22: Particular requirements ● for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1: Safety of Laser Products Part 1: Equipment classification and ● requirements.
IEC 80601-2-60: Medical electrical equipment Part 2-60: Particular requirements ● for the basic safety and essential performance of dental equipment.
. IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -collateral standard: usability

Software Verification and Validation

Software contained in the Epic 980 was developed in accordance with IEC 62304. Software verification and validation testing were performed, and documentation provided in accordance with the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".

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Bench Testing

Ex-vivo testing was conducted on soft tissue to compare performance of the subject device to its predicate. The results demonstrate equivalency.

Clinical Testing

Clinical testing was not performed since there was no change to the intended use and indications for use and the performance characteristics between the subject device and its predicate is equivalent.

VIII. CONCLUSION

Comparison of the Epic 980 subject device with Epic 10 primary predicate (K121286), and two additional reference devices Epic Pro (K163128) and SIROLaser Advance+ (K170500), demonstrates the safety and effectiveness of the Epic 980 and supports substantial equivalence to the identified legally-marketed devices.