CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE

K083379 · Cynosure, Inc. · GEX · Dec 12, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K083379
• Device Name: CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cynosure Smartlipo MPX Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo MPX Laser is futher indicated for laser assisted lipolysis.

Device Story

The Cynosure Smartlipo MPX Laser is a Nd:YAG surgical laser system utilizing a crystal rod medium to generate 1064 nm and 1320 nm wavelengths. The device includes a SmartSense C Module. It is operated by a physician in a clinical setting via a footswitch to deliver laser energy for soft tissue procedures, including incision, excision, vaporization, ablation, coagulation, and laser-assisted lipolysis. The laser energy interacts with target tissues to achieve the desired surgical effect. The system is a floor-standing unit weighing 285 lbs.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Nd:YAG laser system; 1064 nm and 1320 nm wavelengths; crystal rod lasing medium; footswitch activation; 220 VAC, 20A, 50-60 Hz power requirement; dimensions 41"x18"x32".

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (skin, cutaneous/subcutaneous tissue, muscle, cartilage, mucous membrane, lymph vessels/nodes, organs, glands) and 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

• The Cynosure YAG Family laser

Submission Summary (Full Text)

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## 510(K) Summary

Cynosure, Inc. K083379 5 Carlisle Road Westford, MA 01886 George Cho Senior Vice President of Medical Technology November 13. 2008 Cynosure Smartlipo MPX Laser

Medical Laser System

Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810

The Cynosure YAG Family laser

The Cynosure Smartlipo MPX laser with SmartSense C Module is a Nd: YAG laser, having a ND: YAG crystal rod as a lasing medium. It is a laser with a wavelength of 1064 nm and 1320 nm.

Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD).

Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.

The SmartLipo MPX Laser is intended for the surgical incision. excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.

The Cynosure Smartlipo MPX Laser with SmartSense C Module has the same indications for use, the same principle of operation, and the same laser parameters as the predicate device(s).

none

### none

The Cynosure Smartlipo MPX Laser with SmartSense C Module is a safe and effective device for the 'indications for use' specified. none

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynosure, Inc. % Mr. George Cho Sr. Vice President 5 Carlisle Westford, Massachusetts 01886

# DEC 1 2 2008

Re: K083379

Trade/Device Name: Cynosure Smartlipo MPX Laser with SmartSense C Module 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: November 13, 2008 Received: November 14, 2008

Dear Mr. Cho:

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 - Mr. George Cho

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 vours.

Mark N. Millman

- 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): KO8 3379

Device Name: Cynosure Smartlipo MPX Laser with SmartSense C Module Indications For Use:

The Cynosure Smartlipo MPX Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo MPX Laser is futher indicated for laser assisted lipolysis.

Prescriptive Use X OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Net RR. Roda for rent

Division of General, Restorative, and Neurological Devices

**510(k) Number** K083379