SMOOTHKIT+

K082004 · Osyris · GEX · Sep 26, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082004
• Device Name: SMOOTHKIT+
• Applicant: Osyris
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SMOOTHKIT+ is intended for laser assisted lipolysis.

Device Story

SMOOTHKIT+ is a medical laser accessory used for laser-assisted lipolysis. The device consists of a cannula with rounded sharp edges, crimped onto an optical fiber, and a handpiece. The cannula and optical fiber are aligned at the distal end and secured with adhesive. It functions as a delivery system for laser energy during surgical procedures. The device is intended for use by clinicians in a surgical setting. It does not contain electronic components, software, or algorithms.

Clinical Evidence

Bench testing only; biocompatibility data provided.

Technological Characteristics

Medical laser accessory comprising a cannula and optical fiber. Features rounded sharp edges on the cannula. Components are joined with adhesive at the distal end. No energy source, software, or connectivity features. Sterilization method not specified.

Indications for Use

Indicated for laser assisted lipolysis. Patient population not specified.

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

• KIT LIPO (K073617)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

# 5 -1 GENERAL INFORMATION

| Trade Name | SMOOTHKIT+ |
|---------------------|-----------------------------------------------------|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | GEX |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketed | KIT LIPO manufactured by OSYRIS, cleared as K073617 |
| predicate devices | |
| Submitter | OSYRIS |
| | 121 Rue Chanzy, BP 90140 |
| | 59260 HELLEMMES FRANCE |
| Contacts | Pr JAOUAD ZEMMOURI CEO |
| | [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| | Regulatory contact : Dr Isabelle DRUBAIX (Idée |
| | Consulting) [e-mail] |

### 5 -2. DEVICE DESCRIPTION

SMOOTHKIT+ is a medical laser accessory. It includes a cannula crimped on an optical fiber and a handpiece. The extremity of the cannula is sharp edges rounded. The extremities of the cannula and of the optical fiber are in the same plan and there is some adhesive between the cannula and the fiber at the distal end.

### 5 - 3. INTENDED USE

SMOOTHKIT+ is intended for laser assisted lipolysis.

### 5 - 4. PERFORMANCE DATA

Performance data demonstrate the safety and effectiveness (mainly biocompatibity) of SMOOTHKIT+ for its intended use.

### 5 - 5. SUBSTANTIAL EQUIVALENCE

SMOOTHKIT+ has the same intended use, design and function as predicate devices KIT LIPO manufactured by OSYRIS.

Summary preparation date: July, 10, 2008

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osyris c/o Jaquad Zemmouri 121 Rue Chanzy, BP 90140 Hellemmes, France F59260

Re: K082004 Trade/Device Name: Smoothkit+ 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: August 26, 2008 Received: August 28, 2008

Dear Mr. 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 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 - Jaquad Zemmouri

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. Mullen

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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# INDICATIONS FOR USE

510(k) Number (if known): K0820

#### Device Name: SMOOTHKIT+

Indications for Use: SMOOTHKIT+ is intended for laser assisted lipolysis.

Prescription Use ✓ Over-The-Counter Use **__**
AND/OR
(Part 21 CFR 801 Subpart D) (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)

Mark M. Millersen

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

510(k) Number