YA-MAN LASER 21

K032944 · Ya-Man, Ltd. · GEX · Dec 19, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032944
• Device Name: YA-MAN LASER 21
• Applicant: Ya-Man, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.

Device Story

Laser 21 is a diode laser system designed for hair removal. Device emits laser energy to target hair follicles. Operated by clinicians in a professional setting. Output is controlled laser light; used for dermatological procedures. Benefits include permanent reduction of unwanted hair. Device is a prescription-use surgical instrument.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Diode laser system; Class II medical device; Product Code GEX; Regulation 21 CFR 878.4810. Intended for dermatological use.

Indications for Use

Indicated for removal of unwanted hair in patients with Fitzpatrick skin types I-IV.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol is a stylized representation of an eagle or bird with three curved lines forming its wings and body. The seal is black and white and appears to be of official nature.

DEC 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ya-Man Ltd c/o Mr. Robert T. Handren, Jr., M.S. Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, Florida 34748

Rc: K032944 Trade/Devicc Name: Laser 21 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: September 17, 2003 Received: September 29, 2003

Dear Mr. Handren:

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 gencral 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. I'DA may publish further announcements concerning your device in the Federal Register.

Please he advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a dotermination 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 sct 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.

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Page 2 - Mr. Robert T. Handren, Jr., M.S.

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), plcase 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 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

Sincercly yours.

sincerely yours,

Mark N Melkusso

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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510(k) Number (if known):

:

K032944

Device Name: Laser 21

Indications For Use:

The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-----------------------------------------------------|
| Prescription Use | <div> <span style="font-size: 2em;">✓</span> </div> |

OR

| Over-The-Counter Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|

(Optional Format 1-2-96)

for Mark N. Milliken

Vision Technology Representative

Audiological Devices

K032944