PITANGA

K031489 · Syneron Medical, Ltd. · GEX · Aug 19, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031489
• Device Name: PITANGA
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pitanga is intended for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions.

Device Story

Pitanga is a dermatological device for hair removal and treatment of benign vascular/pigmented lesions. It utilizes selective electromagnetic thermolysis, combining optical and RF energy. Parameters (spectrum, exposure duration, energy density) are optimized to target lesions while sparing surrounding tissue. Used in clinical settings by trained professionals. Output consists of controlled energy delivery to the skin surface. Clinical benefit includes non-invasive removal of unwanted hair and reduction of vascular/pigmented skin conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance analysis compared to predicate devices.

Technological Characteristics

Device utilizes selective electromagnetic thermolysis combining optical and RF energy. Parameters include adjustable spectrum, exposure duration, and energy density. Class II device (21 CFR 878.4810, Product Code GEX).

Indications for Use

Indicated for hair removal on all skin types and treatment of superficial benign vascular lesions (Facial/leg Telangiectasias, Rosacea, Poikiloderma, Angioma) and superficial benign pigmented lesions.

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

• Aurora DS (K021149)
• Aurora SR (K022266)
• Lumenis family of intense pulse light (IPL) and IPL/Nd:YAG laser systems (K020839)

Submission Summary (Full Text)

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## AUG 1 9 2003

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. PITANGA K031489

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter: Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550, Yokneam Elite 20692, Israel. Tel. [phone] ext. 7604, Fax [phone]

Name of the Device: Pitanga family of products

- The Pitanga is substantially equivalent to a combination of the Predicate Devices: following devices: the Aurora DS, manufactured by Syneron Medical Ltd. and subject of K021149 ; the Aurora SR, manufactured by Syneron Medical Ltd. and subject of K022266. Lumenis family of intense pulse light (IPL) and IPL/Nd:YAG laser systems manufactured by Lumenis Inc. and subject of K020839.
- Device Description: The Pitanga is a device that is used for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions. The Pitanga treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.

The Pitanga is intended for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions.

Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the Pitanga should raise no new issues of safety or effectiveness.

May 8, 2003

Avis Waldum

Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.

Date

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2003

Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical, Inc. Sultam Industrial Park P.O.B 550 Yokneam Elite 20692. Israel

Re: K031489 Trade/Device Name: Pitanga family of products 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: May 8, 2003 Received: May 21, 2003

Dear Dr. Waldman:

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 mav 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 (OS) 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 - Dr. Amir Waldman

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), 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Millican

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)______________________________________________________________________________________________________________________________________________________

Device Name

Indications For Use:

The Pitanga is indicated for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superfícial benign pigmented lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109)

OR

Over The Counter Use_

(Optional Format 1-2-96)

f. Merle A. Mullener

1, Restorative

510 Number K031489