DERMA YAG

K062762 · El.En Electronic Engineering Spa · GEX · Mar 1, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062762
• Device Name: DERMA YAG
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Derma YAG Laser is indicated for benign vascular lesions and hair removal.

Device Story

Derma YAG is a pulsed Nd:YAG laser system (1064nm wavelength) used in dermatology. Device utilizes Nd:YAG crystal as lasing medium. Operated by physician via footswitch. System is a floor-standing unit (80cm x 42cm x 80cm; 63kg) requiring 220VAC power. Laser energy is delivered to target tissue to treat vascular lesions or remove hair. Clinical benefit derived from laser-tissue interaction for dermatological conditions.

Clinical Evidence

No clinical data provided; no nonclinical performance data provided.

Technological Characteristics

Pulsed Nd:YAG laser; 1064nm wavelength; 220VAC, 12A, 50-60 Hz power; floor-standing form factor (80x42x80 cm); footswitch activation.

Indications for Use

Indicated for patients requiring treatment of benign vascular lesions and hair removal.

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

• Smartepil Laser (K062762)

Submission Summary (Full Text)

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## 510(K) Summary

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K062762

| Submitter: | El.En. S.p.A.<br>via Baldanzese, 17<br>50041 Calenzano (FI), Italy |
|------------------------|--------------------------------------------------------------------|
| Contact: | Andrea Tozzi<br>Quality System Manager & Official Correspondent |
| Date Summary Prepared: | September 5, 2006 |

MAR 01 2007

| Device Trade Name: | Derma YAG |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | Smartepil Laser |
| Device Description: | The Derma YAG Laser is a pulse Nd:YAG laser utilizing the<br>Nd:YAG crystal as the lasing medium. It is a pulsed laser with<br>a wavelength of 1064nm.<br><br>Laser activation is by a footswitch. Overall weight of the laser<br>is 63 kg, and the size is 80 cm x 42 cm x 80 cm<br>(H x W x D).<br><br>Electrical requirement is 220VAC, 12A, 50-60 Hz, single<br>phase. |
| Intended Use: | The Derma YAG Laser is indicated for benign vascular<br>lesions and hair removal. |
| Comparison: | The Derma YAG Laser is substantially equivalent to the<br>Cynosure Smartepil Laser. They are both pulse Nd:YAG lasers<br>for the identical indications for use. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Derma YAG Laser is another safe and effective device for<br>dermatological vascular lesions and hair removal. |
| Additional Information: | None |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, a traditional symbol of medicine, with three diagonal lines above it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

El.En.S.p.A. % Ms. Andrea Tozzi Quality System Manager and Official Correspondent Via Baldanzese, 17 50041 Calenzano (FI), Italy

MAR 0 1 2007

Re: K062762

Trade/Device Name: Derma YAG Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: January 10, 2007 Received: January 12, 2007

Dear Ms. Tozzi:

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

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Page 2 - Ms. Andrea Tozzi

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. product radiance for begin marketing your device as described in your Section 510(k) rran reket 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] 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/industry/support/index.html.

Sincerely yours,

Mark A. Millerman

Mark N. Melkerson 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): _ KO (27 b 2

Device Name: _________ Derma YAG

Indications For Use:

The Derma YAG Laser is indicated for benign vascular lesions and hair removal.

Prescriptive Use (Part 21 CFR 801 Subpart D) Over-the-Counter Use (Part 21 CFR 801 Subpart C)

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

1062762

(Optional Format 1-2-96)