Epic Pro

K163128 · Biolase, Inc. · GEX · Jan 11, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163128
• Device Name: Epic Pro
• Applicant: Biolase, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epic Pro with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indications 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, 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 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 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.

Device Story

Epic Pro is a 980 nm diode laser system for dental and general soft tissue surgery. It uses a semiconductor diode source to deliver infrared radiation via a flexible fiber and handpiece to the treatment site. The device is activated by a wireless footswitch. It operates in continuous wave (CW) or pulsed modes, with output power controlled by thermal feedback from the fiber tip. The system features a color touch screen for parameter control. It is used by clinicians in dental or surgical settings to perform procedures like incision, excision, and coagulation. The device provides precise tissue interaction, aiding in hemostasis and reducing post-operative discomfort. Modifications from the predicate include a detachable fiber cable, wireless footswitch, and updated pulse mode capabilities allowing higher peak powers.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility testing (ISO 10993-1), electrical safety/EMC testing (IEC 60601 series), software verification/validation, and in-vitro bench testing comparing performance to the predicate.

Technological Characteristics

980 nm semiconductor diode laser; max output 25W; CW and pulsed modes; wireless footswitch; color touch screen interface; air-cooled; fiber optic delivery system with disposable tips. Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 80601-2-60.

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. Specific procedures include frenectomy, biopsy, gingivectomy, implant recovery, and sulcular debridement. Also indicated for light activation of bleaching materials for 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

• stLase (K111689)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 11, 2017

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

Re: K163128

Trade/Device Name: Epic Pro 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: December 12, 2016 Received: December 14, 2016

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -A

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

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## Indications for Use

510(k) Number (if known) K163128

Device Name Epic Pro

### Indications for Use (Describe)

The Epic Pro with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indications 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, 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 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 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)

| 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: [phone] Fax: [phone] Contact Person: Alicia Mszyca Date Prepared: November 4, 2016

#### II. DEVICE

| Name of Device: | Epic Pro Diode Laser System |
|----------------------|-------------------------------------------------------------------------------------------------------|
| 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 |

#### III. PREDICATE DEVICE

stLase, K111689

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

Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening.

Epic Pro 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 at 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.

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### V. INDICATIONS FOR USE

The 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 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 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 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 is a modified version of its predecessor, stLase (K111689) to include a new delivery system, wireless footswitch, and some software changes which are aimed to improve functionality and user experience. The intended use, indications for use and the fundamental scientific technology of the subject device, Epic Pro, and the predicate device, stLase, are the same.

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Similarities:

- . The same technical design and operation;
- The same laser source, a semiconductor diode with the wavelength of 980 nm; ●
- The same max output power of 25W;
- The same aiming beam;
- Both devices are available in continuous wave (CW) and pulsed mode and may be ● used in contact and non-contact mode;
- Output power in CW mode can be controlled through the thermal feedback signal ● from end of the fiber (tip):
- Both devices are software-operated and the parameters are controlled by a touch screen control panel;

The key differences between the subject and the predicate device include:

- The predicate device employs a fiber delivery system in the form of strippable ● fiber consisting of a fiber optic connector, cable, handpiece and disposable adapters to hold fiber in the distal part. The modified device utilizes a detachable fiber cable that is used in conjunction with a multi-tip handpiece and disposable fiber tips;
- The predicate device is activated by means of a wired footswitch, whereas the subject device uses a wireless footswitch;
- Modification of pulse mode, allowing the laser to operate at higher peak powers (up ● to 150 W) using very short pulses (down to 10 microseconds) with average power below 25 W;
- . Output power in pulse mode can also be controlled through the thermal feedback signal from end of the fiber (tip);

| Specification | Biolase, Inc<br>Epic Pro<br>(subject device) | Biolase, Inc<br>(prior Dental Photonics, Inc.)<br>stLase/ K111689<br>(predicate device) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser source | Diode | Diode |
| Wavelength | 980 nm | 980 nm |
| Max output power | 25 W | 25 W |
| Power range | 0.2-25 W | 0.5-25 W |
| Increments | 0.2-1 W | 0.1-0.5 W |
| Operating modes | Pulsed or CW | Pulsed or CW |
| Pulse width (duration) | 0.01-100 ms | 0.025 - 3 ms |
| Max pulse peak<br>power | 150 W | 25 W |
| | | |
| Timer duration | 50 ms to 99.9 s | 50 ms to 99.9 s |
| Spot size | 300 - 400 microns | 200 - 400 microns |
| Fluence per spot | 3 - 360 $W/mm^2$ | 3 - 800 $W/mm^2$ |
| Frequency (repetition<br>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…