F1 DIODE LASER SYSTEM

K030235 · Opus Medical, Inc. · GEX · Apr 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030235
• Device Name: F1 DIODE LASER SYSTEM
• Applicant: Opus Medical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Device is indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.

Device Story

F1 Diode Laser System delivers pulsed 810 nm infrared laser light for hair removal/reduction. System components: cabinet housing laser diode, power supply, PC-104, microcontroller; umbilical fiber optics delivery system; handpiece; external TE chiller. Used in dermatology and plastic surgery settings by clinicians. Device transforms electrical power into pulsed laser energy via diode source. Output is laser light applied to skin for hair follicle treatment. Clinical benefit: permanent hair reduction.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

810 nm pulsed diode laser; includes cabinet, power supply, PC-104, microcontroller, fiber optic delivery, handpiece, and external TE chiller. Class II laser surgical instrument.

Indications for Use

Indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.

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

• Opus Medical F1 Diode Laser System
• Lumenis LightSheer™ Pulsed Diode Array Laser System
• Iridex Iriderm Apex 800
• Altus Medical Modified CoolGlide Aesthetic Lasers

Submission Summary (Full Text)

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30235

APR 2 3 2003

### 510(K) SUMMARY

Date: 21 January 2003

Submission Correspondent: Emergo Group, Inc.

Address: 1684 East Gude Drive, Suite 202 Rockville, MD 20850

[phone] Phone: Fax: [phone]

Contact: Mr. Rene van de Zande

| Trade Name: | F1 Diode Laser System |
|-----------------|------------------------------------------|
| Common Name: | Pulsed Diode Laser |
| Classification: | Laser Instrument, Surgical, Powered: GEX |

Description: The F1 Diode Laser System delivers a pulsed infrared laser light at a wavelength of 810 nanometers. The laser consists of several interconnected sections: The cabinet which houses the laser diode, the power supply, the PC-104, and the microcontroller, the umbilical which houses the fiber optics delivery system, and the handpiece and the external TE chiller.

Intended Use: The Device is indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.

Predicate Devices: The predicate devices referenced in this submission are: the Opus Medical F1 Diode Laser System for the existing indication, the Lumenis LightSheer™ Pulsed Diode Arrav Laser System, Iridex Iriderm Apex 800, and the Altus Medical Modified CoolClide Aesthetic Lasers.

#### Summary and Conclusions Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The differences between theF1 Diode Laser System and the predicate devices cited do not raise any different questions regarding safety and effectiveness. The differences in the technological characteristics are minimal. Furthermore, the subject of this submission is identical to the previously cleared F1 Diode Laser System with the exception of the indications for use. The new indications are nearly identical to the indications of two of the predicate devices.

The device, as designed, is as safe and effective as the predicate devices, and the device is substantially equivalent to the referenced predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2003

APR 23 20

Opus Medical, Inc. c/o Ms. Rene van de Zande President Emergo Group, Inc. 1684 East Gude Drive, Suite 202 Rockville, Maryland 20850

Re: K030235

Trade/Device Name: F1 Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 22, 2003

Dear Ms. van de Zande:

Received: January 23, 2003

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Rene van de Zande

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at [phone]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

for Mark N. Milliken

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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Page 1 of 1

510(k) Number (if known): _/< ( 3 ) /

Device Name: F1 Diode Laser System

Indications for Use:

The Device is indicated for hair removal and permanent hair reduction in dermatology and plastic surgery procedures.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milkman

Division Sign-Off) Division o General, Restorative and Neurological Devices

510(k) Number -

(Optional Format 3-10-98)

03023

(Posted July 1, 1998)

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