MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER

K014234 · Continuum Electro-Optics, Inc. · GEX · Jan 17, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014234
• Device Name: MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
• Applicant: Continuum Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology Removal or lightening of unwanted hair with or without adjuvant preparation

Device Story

Medlite C6 Q-Switched Nd:YAG laser system; utilizes Q-switched laser technology for dermatological applications. Device delivers high-energy light pulses to target tissues; used for tattoo removal, vascular/pigmented lesion treatment, soft tissue surgery, and hair removal. Operated by clinicians in medical settings. System design integrates subsystems from previous Continuum Medlite models. Output consists of laser energy for therapeutic tissue interaction; clinical benefit includes removal of unwanted pigment, hair, or vascular structures and surgical tissue management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Q-switched Nd:YAG laser system. Designed as a medical laser surgical instrument. Integrates subsystems from previous Medlite product lines. Operates as a powered laser surgical instrument.

Indications for Use

Indicated for tattoo removal (dark/light inks), treatment of vascular lesions (port wine birthmarks, telangiectasias, spider/cherry angiomas, spider nevi), treatment of pigmented lesions (cafe-au-lait, solar/senile lentigines, Becker's nevi, freckles, nevus spilus, nevus of Ota), soft tissue surgery (incision, excision, ablation, vaporization) in general dermatology, and hair removal/lightening.

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™ IV Q-Switched Nd:YAG Laser
• Medlite™ Q-Switched Nd:YAG Laser
• Medlite™ C3 Q-Switched Nd:YAG Laser

Submission Summary (Full Text)

{0}------------------------------------------------

| 510(k) Summary | K014234 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | Continuum Electro-Optics, Inc.<br>3150 Central expressway<br>Santa Clara, CA 95051 | JAN 1 7 2002 |
| Contact: | Ronald Kohlhardt | |
| Date Summary Prepared: | December 19, 2001 | |
| Device Trade Name: | Medlite C6 Q-Switched Nd:YAG Laser | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX | |
| Equivalent Device(s): | Medlite™ IV Q-Switched Nd:YAG Laser<br>Medlite™ Q-Switched Nd:YAG Laser<br>Medlite™ C3 Q-Switched Nd:YAG Laser | |
| Intended Use: | ● Tattoo Removal<br>● Treatment of Vascular Lesions<br>● Treatment of Pigmented Lesions<br>● Incision, Excision, Ablation, Vaporization of Soft Tissue for<br>General Dermatology<br>● Removal or lightening of unwanted hair with or without adjuvant preparation | |
| Comparison: | The Medlite C6 Q-Switched Nd:YAG Laser bases its<br>design/construction from the integration of primary subsystems<br>extracted from legally marketed predicate Continuum products. The<br>new device performs and is specified within all product parameters<br>of the predicate devices. | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Additional Information: | None | |

:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 7 2002

Continuum Electro-Optics, Inc. Ronald Kohlhardt Director, Regulatory Compliance and Quality Assurance 3150 Central Expressway Santa Clara, California 95051-0801

Re: K014234

Trade Name: Medlite C6 Q-Switched Nd: YAG Laser Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: December 19, 2001 Received: December 26, 2001

Dear Mr. Kohlhardt:

We have reviewed your Section 510(k) premarket 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) 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 (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.

{2}------------------------------------------------

Page 2 - Mr. Ronald Kohlhardt

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisting of substantial equivalence of your device to a legally premarket notification: "The Privating sification 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 If you desire specific acriso to: you in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 607.10 Idditionally, for questions on the promotion and advertising of Compilance at [phone]. Freeded Compliance at [phone]. Also, please note the your do roo, pread o concerner to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your new 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,

Mark N. Milken

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

{3}------------------------------------------------

## 510(k) Number (if known): K014234

Device Name:

Medlite C6 Q-Switched Nd: YAG Laser.

Indications for Use:

Tattoo Removal

- dark ink: blue and black ●
- light ink: red .
- light ink: sky blue .
- light ink: green .

Treatment of Vascular Lesions

- port wine birthmarks .
- telangiectasias ●
- spider angioma ●
- cherry angioma .
- spider nevi ●

Treatment of Pigmented Lesions

- cafe-au-lait birthmarks .
- solar lentiginos .
- senile lentiginos �
- becker's nevi .
- freckles .
- nevus spilus .
- nevus of ota

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Removal or lightening of unwanted hair with or without adjuvant preparation

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Miller

Divisio Sign-Cim i islop of General. Restorative and Neuronogical Devices

K014234 210(k) Number_

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)