MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER

K983054 · Continuum Biomedical, Inc. · GEX · Feb 10, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K983054
• Device Name: MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
• Applicant: Continuum Biomedical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.

Device Story

Medlite Q-Switched Nd:YAG Laser system; utilizes laser energy for hair removal/lightening. Device operates in 1064nm mode; eliminates requirement for adjuvant preparation (e.g., lotions). Used in clinical settings by trained professionals. Output is laser energy applied to skin; facilitates hair removal/lightening. Benefits patient by providing effective hair management without preparatory steps.

Clinical Evidence

Clinical data provided to support the use of the Medlite Q-Switched Nd:YAG Laser systems without preparatory lotion. Results demonstrated safe removal or lightening of unwanted hair without adverse clinical findings.

Technological Characteristics

Q-Switched Nd:YAG laser system; 1064nm wavelength; powered surgical laser; Class II device. Operates without adjuvant preparation.

Indications for Use

Indicated for the removal or lightening of unwanted hair in patients requiring hair reduction or lightening, specifically utilizing the 1064nm mode without the need for adjuvant preparation.

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

• Medlite™ Q-Switched Nd:YAG Laser, Medlite™ IV Q-Switched Nd:YAG Laser (K973719)
• ThermoLase LT-100 Nd: YAG Laser Hair Removal System (K950019)

Submission Summary (Full Text)

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2/10/99

510(k) Premarket Notification - Original Submission
Medlite™ Laser Systems Continuum Biomedical
August 31, 1998

983054

## 510(k) Summary

| Submitter: | Continuum Biomedical<br>A Medical Division of Continuum Electro-Optics, Inc.<br>6533 Sierra Lane<br>Dublin, CA 94568<br>Phone: [phone]<br>Fax: [phone] | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Laurie A. Ridener<br>Regulatory Affairs Officer | |
| Date Summary Prepared: | August 31, 1998 | |
| Device Trade Name: | Medlite™ Q-Switched Nd:YAG Laser<br>Medlite™ IV Q-Switched Nd:YAG Laser | |
| Common Name: | Medical laser system | |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CRF 878.48 | |
| Equivalent Device: | Medlite™ Q-Switched Nd:YAG Laser, Medlite™ IV Q-Switched<br>Nd:YAG Laser (K973719, SE date 12/23/97)<br>ThermoLase LT-100 Nd: YAG Laser Hair Removal System<br>(K950019, SE Date 04-03-95) | |
| Intended Use: | For the removal or lightening of unwanted hair without adjuvant<br>preparation | |
| Comparison: | Equivalent | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | Clinical data was provided to support the use of the Medlite™ Q-<br>Switched Nd:YAG Laser Systems without preparatory lotion to safely<br>remove or lighten unwanted hair without adverse clinical findings. | |
| Additional Information: | None requested at this time | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical 6533 Sierra Lane Dublin, California 94568

Re: K983054

Trade Name: Medlite™ Q-Switched Nd:YAG Laser Medlite™ IV Q-Switched Nd:YAG Laser Regulatory Class: II Product Code: GEX Dated: December 3, 1998 Received: December 4, 1998

Dear Ms. Ridener:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Laurie A. Ridener

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from 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,

peoleda

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification - Original Submission Medlite™ Laser Systems Continuum Biomedical Revised February 5, 1999

Page 1 of 1

P.

| 510(k) Number (if known): | K983054 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Medlite™ Q-Switched Nd:YAG Laser<br>Medlite™ IV Q-Switched Nd:YAG Laser |
| Indications for Use: | For the removal or lightening of unwanted hair in the 1064nm<br>mode only without adjuvant preparation using one or two<br>treatments. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center"></div> |
|-----------------------------------------|----------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K483054 |

| Prescription Use (Per 21 CFR 801.109) | X |
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OR
Over-the-Counter Use ______ (Optional Format 1-2-96)PROPRIETARY DATA: This document and information contained berrin may not be reproduced, wood or disclosed without written partission of Continuen Biomedical A Medial Dricion of Continuan Plection Optics, Inc.