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

K973719 · Continuum Biomedical, Inc. · GEX · Dec 23, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973719
• 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: Dec 23, 1997
• 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.

Device Story

Medlite Q-Switched Nd:YAG Laser and Medlite IV Q-Switched Nd:YAG Laser are medical laser systems designed for hair removal or lightening. The device operates in the 1064nm mode to target hair follicles. It is intended for use by healthcare professionals in a clinical setting. The laser energy is applied to the skin to achieve the desired cosmetic effect of hair reduction or lightening. The device functions as a powered surgical laser instrument.

Clinical Evidence

No new clinical data was generated for this submission. The manufacturer relied on clinical performance data previously authorized for access from the predicate device (K950019).

Technological Characteristics

Q-Switched Nd:YAG laser system operating at 1064nm. Powered surgical laser instrument (Product Code GEX).

Indications for Use

Indicated for the removal or lightening of unwanted hair.

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

• ThermoLase LT-100 Nd:YAG Laser Hair Removal System (K950019)

Submission Summary (Full Text)

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## K973719

## 510(k) Summary

DEC 2 3 1997

| 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: | September 29, 1997 | | |
| 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: | 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 | | |
| Comparison: | Equivalent | | |
| Nonclinical Performance Data: | None | | |
| Clinical Performance Data: | Authorization provided to access data in K950019 | | |
| Conclusion: | The Medlite Laser Systems can be safely used to remove or lighten<br>unwanted hair | | |
| 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 features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1997

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

Re: K973719

> Trade Name: Medlite™ Q-Switched Nd: YAG Laser, Medlite IV Q-Switched Nd: YAG Laser Regulatory Class: II Product Code: GEX Dated: September 29, 1997 Received: September 30, 1997

Dear Ms. Ridener:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542

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Page 2 - Ms. Ridener

of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

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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长973719 510(k) Number (if known):

Device Name:

Medlite™ Q-Switched Nd:YAG Laser Medlite™ IV Q-Switched Nd:YAG Laser

Indications for Use:

For the removal or lightening of unwanted hair in the 1064nm mode only.

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| | Concurrence of CDR Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | |

Prescription Use _/_
OR
Over-the-Counter Use ____

(Per 21 CFR 801.109)
(Optional Format 1-2-96)

PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continuum Biomedical, A Medical Division of Continuum Electro-Optics, Inc.