ELIPO

K073715 · Syneron Medical, Ltd. · GEX · Apr 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073715
• Device Name: ELIPO
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (eLipo) is further indicated for laser-assisted lipolysis.

Device Story

LipoLite (eLipo) is a microprocessor-controlled 1064 nm Nd:YAG laser system. Device components include high voltage power supply, laser assembly, control panel, and cooling unit. System delivers pulsed laser energy to pre-determined anatomical areas via optical fiber. Used by clinicians in dermatological and plastic surgery settings for soft tissue procedures and laser-assisted lipolysis. Output allows for precise tissue interaction (incision, excision, vaporization, ablation, coagulation). Benefits include controlled thermal effect on soft tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications compared to the predicate device.

Technological Characteristics

1064 nm Nd:YAG laser system; microprocessor-controlled; pulsed energy delivery via optical fiber; includes high voltage power supply, laser assembly, control panel, and cooling unit.

Indications for Use

Indicated for dermatological procedures requiring incision, excision, vaporization, ablation, and coagulation of soft tissue, and for laser-assisted lipolysis.

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

• Cynosure SmartLipo Laser (K062321)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: Syncron Medical Ltd., Industrial Park, P.O.B. 550 Yokneam Illit, 20692, Israel Tel. [phone] (ext. 591); Fax [phone]

Name of the Device: LipoLite (eLipo)

Predicate Devices: This is a 510(k) submission for the LipoLite (eLipo) device that is substantially equivalent to the following cleared device: Cynosure SmartLipo Laser (Cynosure Inc., K062321).

- Device Description: The LipoLite (eLipo) is a microprocessor-controlled 1064 nm Nd: YAG laser system. It is composed of the following main units: high voltage power supply, laser assembly, control panel and cooling unit. The LipoLite (eLipo) delivers pulsed energy to pre-determined anatomical areas via an optical fiber.
- Indications for Use: The LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (eLipo) is further indicated for laser-assisted lipolysis.

Conclusion: The overall specifications, principle of operation, performance characteristics and indications for use of the LipoLite (eLipo) device are substantially equivalent to those of the predicate device. Therefore, the LipoLite (eLipo) device should raise no new issues of safety and effectiveness and is safe and effective for the indicated uses.

Sonie I.

April 10, 2008 Date

oni Iger, Ph.D. Director of Clinical & Regulatory Affairs Syneron Medical Ltd.

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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 features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Syneron Medical Ltd. % Yoni Iger Industrial Zone, P.O. Box 550 Yokneam Illit 20692, Israel

APR 2 3 2008

Re: K073715 Trade/Device Name: LipoLite (eLipo) 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: April 12, 2008 Received: April 17, 2008

Dear Yoni Iger:

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 - Yoni Iger

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 M. Mulhausen

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): K67 3 アレバ

Device Name: LipoLite (eLipo)

Indications for Use:

The LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (cLipo) is further indicated 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)

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Division of General, Restorative, Page 1 of 1 and Neurological Devices

510(k) Number K073715