EPI-STAR SURGICAL LASER SYSTER

K990119 · Nidek, Inc. · GEX · Jul 27, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K990119
• Device Name: EPI-STAR SURGICAL LASER SYSTER
• Applicant: Nidek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Epi-Star Surgical Laser System is for Plastic Surgery The and Dermatology, intended use for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair.

Device Story

Epi-Star Surgical Laser System is a long-pulse diode laser (800 nm) for dermatology and plastic surgery. Device consists of a moveable console with power supplies, optical rail, cooling mechanism, and touch keypad control panel. System uses a separate 635 nm laser diode for aiming. Clinician operates device to deliver laser energy with fluence up to 50 J/cm2, frequency up to 15 Hz, and pulse width up to 100 msec. Output energy targets vascular/pigmented lesions or hair follicles. Device provides therapeutic benefit through controlled thermal tissue interaction. Clinical decision-making relies on clinician assessment of lesion or hair type and manual adjustment of system parameters via the control panel.

Clinical Evidence

No clinical data presented. Substantial equivalence is based on comparison of specifications and indications for use to legally marketed predicate devices. Bench testing only.

Technological Characteristics

Long-pulse diode laser; 800 nm wavelength; 635 nm aiming beam. Fluence up to 50 J/cm2; frequency up to 15 Hz; pulse width up to 100 msec. Solid optical rail construction with integrated cooling system. Complies with 21 CFR 1040.10 and 1040.11.

Indications for Use

Indicated for treatment of vascular and pigmented lesions in dermatology and for hair removal in plastic surgery and dermatology patients.

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

• DioLight 60 (K981447)
• LightSheer (K98420)
• EpiTouch ALEX (K973354)
• GentleLASE (K981351)
• Photogencia LPIR (K971737)

Submission Summary (Full Text)

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## Appendix C

K 990 119

510(k) Summary Statement of Safety and Effectiveness

#### General Information I

Submitter:

Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474

Contact:

Mr. Jerry Tsutsumi Regulatory/Quality Manager

Date of Application:

10 January 1999

#### II Device Name

Trade/Proprietary Name: Model Number:

Epi-Star Diode Surgical Laser System Epi-Star

Classification Name: Common Name:

Laser Instrument, Surgical, Powered Diode Surgical Laser

Device Classification: Product Code: Regulation:

Class II Medical Device GEX 21 CFR 878.4810

#### III Predicate Devices

The Epi-Star CO2 Laser System is substantially equivalent to the following currently marketed devices:

| Manufacturer | Product Model | 510(k) Number | Decision Date |
|--------------------|------------------|---------------|-----------------|
| • Nidek Inc. | DioLight 60 | K981447 | 5 June 1998 |
| • Coherent/Palomar | LightSheer | K98420 | 4 May 1998 |
| • Sharplan Lasers | EpiTouch ALEX | K973354 | 4 December 1997 |
| • Candela Corp. | GentleLASE | K981351 | 13 July 1998 |
| • Cynosure Inc. | Photogencia LPIR | K971737 | 8 August 1997 |

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#### Product Description IV

The Nidek Epi-Star Surgical Laser System consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical rail, and a cooling mechanism to dissipate the heat generated by the system. A touch key pad control panel with alphanumeric displays that enables the user to control the laser systems operating parameters. The Epi-Star Surgical Laser System is a "Long Pulse Diode Laser" which operates at a wavelength of 800 nm, using a Near Infrared Diode Laser Array lasing medium. The system uses a separate laser diode for its aiming beam (635 nm) and the system has a Fluence Range of up to 50 Joules/cm2, variable Frequency Range (Repeat Rate) up to 15 Hz, and variable Pulse Width (Pulse Duration) up to 100 msec. More details are provided in Appendix D.

#### V Indications for Use

Epi-Star Surgical Laser System is for Plastic Surgery The and Dermatology, intended use for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair.

#### Performance Standards VI

The Nidek Incorporated Epi-Star Diode Surgical Laser System is manufactured and designed to comply with the requirements defined in Title 21 CFR 1040.10 and 1040.11, FDA regulations for Medical Laser Products, as applicable.

#### Clinical Performance Data VII

None presented. The specifications and indications for use for the Epi-Star Diode Surgical Laser System are the same or very similar to those of the claimed predicate devices. The Epi-Star Diode Surgical Laser System has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use.

## VIII Non-Clinical Performance Data

None presented.

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#### Rational for Substantial Equivalence IX

Comparison of system specifications between the Nidek Epi-Star Diode Surgical Laser System and the Nidek Dio-Light 60 Diode Surgical Laser System (K981447) are exactly the same, except for the intended use for hair removal. As both of these systems are the same in their methods of operation and physical construction, and both systems utilize the same design, functional, and performance features (as demonstrated in Appendix B), and are therefore substantially equivalent.

Comparison of system specifications and features of the Nidek Epi-Star Diode Surgical Laser System and the other legally marketed predicate devices demonstrates the systems to be equivalent. The systems compared all have the same or similar design, functional, and/or performance features (as demonstrated in Appendix B, Substantial Equivalence Comparison), and are therefore substantially equivalent.

Since the Nidek Epi-Star Diode Surgical Laser System is substantially equivalent with respect to the indications for use, design, methods of operation, physical construction, functional and performance features to other predicated devices, we believe that this device clearly meets the requirements for substantial equivalence according to the 510(k) guidelines. The Safety and Effectiveness are reasonably assured, and therefore justifying 510(k) Premarket Notification Clearance for commercial sale and distribution.

#### Safety and Effectiveness ×

The information provided in Appendix B demonstrates that the Nidek Inc. Epi-Star Diode Surgical Laser System is safe and effective, when indicated for use for general and specific applications in the medical specialties of dermatology and plastic surgery as describe above in Section V.

Appendix D "DEVICE DESCRIPTION" provides information regarding the systems control features and safety features designed into this product to ensure it safe use.

Appendix E provides information on the product development processes used to ensure the products safety and effectiveness during the design process.

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#### Conclusion XI

Thus, with the information provided in this 510(k) Submission, the Nidek Epi-Star Diode Surgical Laser is felt to be substantially equivalent to other similar currently marketed predicate devices. Based on the information provided in Appendix B of this submission, the differences noted in the various products compared DOES NOT pose any new, significant effects on the safety, performance, use or effectiveness of the Epi-Star Diode Surgical Laser System. Thus, the Safety and Effectiveness of this product is reasonably assured for use in hair removal.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "HUMAN SERVICES - USA DEPARTMENT" surrounding it. The text is arranged along the circumference of the circle, with "HUMAN SERVICES" at the top and "DEPARTMENT" at the bottom.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 27 2000

Nidek, Inc. c/o Ms. Carol L. Patterson Patterson Consulting Group 21911 Erie Lane Lake Forest, California 92630

K990119 Re:

Trade Name: Epi-Star Diode Surgical Laser System Regulatory Class: II Product Code: GEX Dated: April 28, 2000 Received: May 3, 2000

Dear Ms. Patterson:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your bootion of o(x) ce is substantially equivalent (for the indications for above and we have dosure) to devices marketed in interstate commerce prior to use stated in the cherosure) to de roos in he Medical Device Amendments, or to devices that May 20, 1770, the enactivent date ee with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costlience Act (Act). " Fournaly, the controls provisions of the Act include requirements for provisions of the Frea "ing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major (1 remarket / tpproval), it may of can be found in the Code of Federal Regulations, Title 21, regulations arrooting 70at with equivalent determination assumes compliance with the I arts 600 to 095. 11 babban and Practice requirement, as set forth in the Quality System Current Good Manatetaling Previces: General regulation (21 CFR Part 820) and that, Regulation (QD) inspections, the Food and Drug Administration (FDA) will verify through perfours (QS) inspreasomply with the GMP regulation may result in regulatory Such assumptions: Tunal to volupish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does rederal Register. Prease now night have under sections 531 through 542 of the Act for not arrect any oongation you might in adiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Carol L. Patterson

This letter will allow you to begin marketing your device as described in your 510(k) This letter will and in Jourse Finding of substantial equivalence of your device to a premarket notification. - The evice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of and additionally 6091594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the notification (21 OF IC on the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. bochner.

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

K990119 510(k) Number (if known): _

Device Name: Nidek Inc. Epi-Star Laser System

Indications for use: The Epi-Star Surgical Laser System is intended to be used for Hurcations for aber The Lp ology, with the intended uses for the treatment of r ascular and pigmented lesions in dermatology, and for the removal of hair.

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma P. Vochner.

(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
Division of General Restorative Devices Division of Sen Kagon J

Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use