Who is the manufacturer of Epic 980?

Biolase, Inc. filed the 510(k) submission for Epic 980 (K192430).

What is the FDA product code for Epic 980?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Epic 980?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Epic 980?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Epic 980

K192430 · Biolase, Inc. · GEX · Dec 4, 2019 · General, Plastic Surgery

Device Facts

Record ID	K192430
Device Name	Epic 980
Applicant	Biolase, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Dec 4, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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: - 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 2. 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) 3. Whitening - Light activation for bleaching materials for teeth whitening - Laser-assisted whitening/bleaching of teeth 4. 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.

Device Story

Epic 980 is a dental diode laser system for oral soft-tissue surgery, periodontal procedures, teeth whitening, and pain therapy. It uses an Indium Gallium Arsenide (InGaAs) solid-state laser diode to emit 980nm infrared energy. Energy is transmitted via a flexible fiber optic cable to a handpiece with single-use disposable tips. A visible aiming beam identifies the treatment site. The system includes a base console and a wireless footswitch. Operated by dental professionals in a clinical setting. The device provides precise tissue interaction for surgical procedures and thermal energy for pain relief. It benefits patients by enabling minimally invasive soft-tissue management and therapeutic pain reduction.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (ex-vivo soft tissue performance comparison) and compliance with electrical safety/EMC standards (IEC 60601 series, IEC 60825-1).

Technological Characteristics

InGaAs solid-state diode laser; 980nm wavelength; 10W max output; continuous/pulse modulation modes; fiber optic delivery with quartz single-use tips; wireless footswitch; touch screen interface. Materials: medical grade plastics, steel, stainless steel, aluminum, brass. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, IEC 60601-1-6.

Indications for Use

Indicated for dental soft tissue procedures (incision, excision, ablation, coagulation, biopsies, frenectomy, gingivectomy, etc.), periodontal procedures (curettage, sulcular debridement), teeth whitening, and pain therapy (topical heating for minor muscle/joint pain, stiffness, arthritis, or muscle spasm).

Regulatory Classification

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.

Predicate Devices

Epic 10 (K121286)

Reference Devices

Epic Pro (K163128)
SIROLaser Advance + (K170500)

Related Devices

K193486 — Epic 980 · Biolase, Inc. · Mar 16, 2020
K162114 — Photon, Photon Plus · Zolar Technology & Mfg Co., Inc. · Dec 12, 2016
K121286 — EPIC 10 · Biolase Technology, Inc. · Sep 28, 2012
K172771 — Epic Pro 940 · Biolase, Inc. · Nov 29, 2017
K123443 — PRECISE SHP DIODE LASER · CAO Group, Inc. · Aug 13, 2013

Submission Summary (Full Text)

{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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192430 Device Name Epic 980 Indications for Use (Describe) 1. 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 - 2. 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) - 3. Whitening - · Light activation for bleaching materials for teeth whitening - · Laser-assisted whitening/bleaching of teeth - 4. 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) ### 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 r i no burden instructions, search existing data sources, gather and maintain the data needed and complete time to roview the collection. 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 OMB number." {4}------------------------------------------------ ## 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}------------------------------------------------ {10}------------------------------------------------ ## 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". {11}------------------------------------------------ ## 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.