Epic Pro 940

K172771 · Biolase, Inc. · GEX · Nov 29, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172771
• Device Name: Epic Pro 940
• Applicant: Biolase, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: 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: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). The Epic Pro 940 with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue. The Epic Pro 940 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: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, pulpotomy as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.

Device Story

Epic Pro 940 is a diode laser system for soft-tissue surgery and dental whitening. Device uses solid-state diode to generate invisible infrared radiation (940nm). Energy delivered via flexible fiber optic cable to handpiece with single-use disposable tips. Activated by wireless footswitch. Operated by clinicians in dental or surgical settings. Features Automatic Power Control. Provides precise tissue interaction for incision, excision, vaporization, ablation, hemostasis, and coagulation. Clinical benefit includes minimally invasive soft tissue management and efficient dental whitening. Healthcare providers use color touch screen to control parameters; output affects tissue directly via thermal energy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and ex-vivo animal tissue testing comparing subject device to predicate. Biocompatibility, electrical safety (IEC 60601-1, 60601-2-22), and EMC testing performed per recognized standards.

Technological Characteristics

Solid-state diode laser; 940 nm wavelength; 0.2-25 W power range; pulsed or CW modes; 300-400 micron spot size; air-cooled; color touch screen interface; wireless footswitch activation; fiber optic delivery system. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, IEC 62366-1, and IEC 60601-1-6.

Indications for Use

Indicated for dental and general surgery soft tissue procedures including incision, excision, vaporization, ablation, hemostasis, and coagulation. Applicable to intraoral and extra-oral soft tissue, including gingiva and periodontal pockets. Used for various dental procedures (e.g., frenectomy, biopsy, gingivectomy, implant recovery, pulpotomy) and teeth whitening.

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 Pro (K163128)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

November 29, 2017

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

Re: k172771

Trade/Device Name: Epic Pro 940 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 Dated: September 11, 2017 Received: September 14, 2017

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K172771

Device Name Epic Pro 940 Diode Laser System

### Indications for Use (Describe)

The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indication, incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingival; examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The Epic Pro 940 with surgical laser operation, used in contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.

The Epic Pro 940 with dental laser operation is intended for incision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.

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

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

### 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 [e-mail]

"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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the word "BIOLASE" in a bold, sans-serif font. The word is written in a dark blue color. The letters are evenly spaced and the word is centered in the image.

## SECTION 5

510(k) Summary

Biolase, Inc. Epic Pro 940 – 510(k) Submission

{4}------------------------------------------------

## 510(k) SUMMARY

#### I. SUBMITTER

Biolase, Inc. 4 Cromwell Irvine, CA 92618 USA Tel: [phone] Fax: [phone] Contact Person: Alicia Mszyca Date Prepared: September 11, 2017

#### II. DEVICE

| Name of Device: | <b>Epic Pro 940 Diode Laser System</b> |
|----------------------|-------------------------------------------------------------------------------------------------------|
| 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 |

#### PREDICATE DEVICE III.

Epic Pro, K163128

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION IV.

Epic Pro 940 diode laser system is a surgical device designated for a wide variety of surgical and oral soft-tissue procedures and dental whitening. Epic Pro 940 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.

{5}------------------------------------------------

#### V. INDICATIONS FOR USE

The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: 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: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The Epic Pro 940 with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.

The Epic Pro 940 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: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, pulpotomy as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.

#### VI. SUMMARY OF SIMILARITIES AND DIFFERENCES

Epic Pro 940 is a modified version of Epic Pro (K163128). The change involved is limited to the replacement of the existing 980nm diode laser module, used in Epic Pro, with a 940nm diode in Epic Pro 940.

Epic Pro 940 operates the same as the predicate device and the modification does not impact the intended use and indications for use.

{6}------------------------------------------------

Table 1 - Summary of technological characteristics between the subject and predicate device.

| Table 1 - Summary of technological characteristics between the subject and predicate device | | |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification | Biolase, Inc<br>Epic Pro 940<br>(subject device) | Biolase, Inc<br>Epic Pro/ K163128<br>(predicate device) |
| Laser source | Diode | Diode |
| Wavelength | 940 nm | 980 nm |
| Max output power | 25 W | 25 W |
| Power range | 0.2-25 W | 0.2-25 W |
| Increments | 0.2-1 W | 0.2-1 W |
| Operating modes | Pulsed or CW | Pulsed or CW |
| Pulse width (duration) | 0.01-100 ms | 0.01-100 ms |
| Max pulse peak power | 150 W | 150 W |
| Timer duration | 50 ms to 99.9 s | 50 ms to 99.9 s |
| Spot size | 300-400 microns | 300-400 microns |
| Fluence per spot | 3 – 360 W/mm² | 3 – 360 W/mm² |
| Frequency (repetition rate) | Up to 20 kHz | Up to 20 kHz |
| Aiming beam | 650 nm, 5mW | 650 nm, 5mW |
| Cooling | Air cooled | Air cooled |
| Voltage | 120V/60Hz or 240V/50Hz | 120V/60Hz or 240V/50Hz |
| Control panel | Color touch screen | Color touch screen |
| Laser activation | Wireless footswitch | Wireless footswitch |
| Delivery system | Fiber optic cable, handpiece and disposable fiber tips | Fiber optic cable, handpiece and disposable fiber tips |
| Indications for use | Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty | Epic Pro with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty |

{7}------------------------------------------------

gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining. incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues , and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). Epic Pro 940 with surgical laser operation used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue: and Epic Pro 940 with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site. removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue

gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining. incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues , and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). Epic Pro with surgical laser operation used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue: and Epic Pro with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue

{8}------------------------------------------------

| retraction for impressions, | retraction for impressions, |
|------------------------------------|------------------------------------|
| papillectomy, vestibuloplasy, | papillectomy, vestibuloplasy, |
| excision of lesions, exposure of | excision of lesions, exposure of |
| unerupted/partially erupted teeth, | unerupted/partially erupted teeth, |
| leukoplakia, removal of | leukoplakia, removal of |
| hyperplastic tissues, treatment of | hyperplastic tissues, treatment of |
| aphthous ulcers, sulcular | aphthous ulcers, sulcular |
| debridement (removal of | debridement (removal of |
| diseased or inflamed soft tissue | diseased or inflamed soft tissue |
| in the periodontal pocket), | in the periodontal pocket), |
| pulpotomy, pulpotomy as an | pulpotomy, pulpotomy as an |
| adjunct to root canal therapy, | adjunct to root canal therapy, |
| and light activation of bleaching | and light activation of bleaching |
| materials for teeth whitening. | materials for teeth whitening. |

## VII. PERFORMANCE DATA

The following performance data has been generated in support of substantial equivalence determination:

## 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, as recognized by the FDA. The results demonstrate biocompatibility of the device and its accessories.

## Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and electromagnetic compatibility testing of Epic Pro 940 was conducted according to the recognized standards. The device passed the required testing and is in full compliance with the standards:

- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for ● safety - collateral standard: electromagnetic compatibility (EMC)- requirements and test
- 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

{9}------------------------------------------------

- IEC 80601-2-60: Medical electrical equipment Part 2-60: Particular requirements ● for the basic safety and essential performance of dental equipment
- IEC 62366-1: Medical devices Part 1: Application of Usability Engineering to ● medical devices
- . 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 Epic Pro 940 was developed in accordance with IEC 62304. Software verification and validation testing was performed and documentation provided per the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".

### Bench Testing

Ex-vivo animal tissue testing was performed to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro 940 performs as well as the predicate device, Epic Pro.

### Clinical Testing

Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent.

## VIII. CONCLUSION

Epic Pro 940 has the same intended use, indications for use as well as fundamental scientific technology as its legally marketed predicate. Epic Pro (K163128). Performance data demonstrates that the modification incorporated to Epic Pro 940 does not raise any new safety or efficacy concerns. Therefore, it can be concluded that the Epic Pro 940 device is substantially equivalent to its predicate.