PHARAON LIPO

K073617 · Osyris · GEX · Apr 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073617
• Device Name: PHARAON LIPO
• Applicant: Osyris
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PHARAON LIPO is intended for laser assisted lipolysis

Device Story

PHARAON LIPO is a surgical laser system for laser-assisted lipolysis. The device utilizes a laser module consisting of series-assembled laser diodes emitting a coherent light beam at 970nm ± 10 nm with a maximum power of 25W. The beam is focused into a 600um optical fiber connected via an SMA 905 connector. The system includes power supply components and a thermal management system using a Peltier element and a ventilated radiator. Operational parameters are adjusted by the clinician via a TFT screen and tactile interface. The device is intended for use by physicians in a clinical setting to perform lipolysis, where the laser energy is delivered to target tissue to facilitate fat removal. The system incorporates electronic controls to ensure safe functioning during the procedure.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through bench testing and conformance to FDA guidance documents for medical lasers and software.

Technological Characteristics

Laser surgical instrument; 970nm ± 10 nm wavelength; 25W max power; 600um optical fiber; SMA 905 connector; Peltier element cooling with ventilated radiator; TFT screen with tactile interface; 21 CFR 1040.10/1040.11 compliant.

Indications for Use

Indicated for laser assisted lipolysis in patients requiring surgical fat reduction.

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

• SMARTLIPO (K062321)

Submission Summary (Full Text)

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K073617

510k PHARAON LIPO

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

## 5 -1 GENERAL INFORMATION

| Trade Name | PHARAON LIPO |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | GEX |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketed<br>predicate devices | K062321: SMARTLIPO manufactured by CYNOSURE INC. |
| Submitter | OSYRIS<br>121 Rue Chanzy, BP 90140<br>59260 HELLEMMES FRANCE |
| Contacts | Pr JAOUAD ZEMMOURI CEO<br>[e-mail]<br>Phone : [phone]<br>Fax: [phone]<br>Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting)<br>[e-mail] |

#### 5 -2. DEVICE DESCRIPTION

The medical device PHARAON LIPO is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fiber of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.

In addition PHARAON LIPO includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a TFT screen and a tactile flagstone.

### 5 - 3. INTENDED USE

PHARAON LIPO is intended for laser assisted lipolysis

### 5 - 4, PERFORMANCE DATA

PHARAON LIPO conforms to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).

PHARAON LIPO conforms to 21CFR part 1040.10 and 1040.11.

Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use.

#### 5 - 5. SUBSTANTIAL EQUIVALENCE

PHARAON LIPO has the same intended use, material design and function as predicate device SMARTLIPO (K062321).

Summary preparation date: December 7, 2007

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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 consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 2008

Osyris % Pr Jaouad Zemmouri CEO 121, rue Chanzy, BP 90140 59260 Hellemmes France

Re: K073617

Trade/Device Name: Pharaon Lipo 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: March 26, 2008 Received: March 28, 2008

Dear Pr Jaouad Zemmouri:

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 - Pr Jaouad Zemmouri

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 N. Milliman

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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510k PHARAON LIPO

pg 1 of 1

## INDICATIONS FOR USE

510(k) Number (if known): K073617

Device Name: PHARAON LIPO

Indications for Use: PHARAON LIPO is intended for laser assisted lipolysis

Prescription Use 14 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nef RPB dl. fs mxn

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

**510(k) Number** K073617