CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER

K080121 · Cynosure, Inc. · GEX · Jan 31, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080121
• Device Name: CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartLipo Multiwavelength Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as 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.

Device Story

Nd:YAG laser system; 1064 nm and 1320 nm wavelengths; uses Nd:YAG crystal rod as lasing medium. Operated by physician via footswitch. Used in clinical settings for soft tissue surgery and laser-assisted lipolysis. Laser energy delivered to target tissue to perform incision, excision, vaporization, ablation, or coagulation. Benefits include precise tissue interaction for surgical and lipolysis applications. System is a floor-standing unit (285 lbs).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue (skin, subcutaneous, muscle, cartilage, organs, glands) and laser-assisted lipolysis in patients requiring such procedures.

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 YAG Family laser

Submission Summary (Full Text)

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K080121

| | 510(K) Summary |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Cynosure, Inc. |
| | 5 Carlisle Road<br>Westford, MA 01886 |
| Contact: | George Cho<br>Senior Vice President of Medical Technology |
| Date Summary Prepared: | January 16, 2008 |
| Device Trade Name: | Cynosure Smartlipo Multiwavelength Laser<br>JAN 31 2008 |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 |
| Equivalent Device: | The Cynosure YAG Family laser |
| Device Description: | The Cynosure Smartlipo Multiwavelength laser is a Nd:YAG laser,<br>having a ND: YAG crystal rod as a lasing medium. It is a laser with a<br>wavelength of 1064 nm and 1320 nm. |
| | Laser activation is by footswitch. Overall weight of the laser is<br>285lbs, and the size is 41"x18"x32" (HxWxD). |
| | Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase. |
| Intended Use: | The SmartLipo Multiwavelength Laser is intended for the surgical<br>incision, excision, vaporization, ablation, and coagulation of soft<br>tissue. All soft tissue is included, such as skin, cutaneous tissue,<br>subcutaneous tissue, striated and smooth tissue, muscle, cartilage<br>meniscus, mucous membrane, lymph vessels and nodes, organs and<br>glands. The SmartLipo is further indicated for laser assisted lipolysis. |
| Comparison: | The Cynosure Smartlipo Multiwavelength Laser has the equivalent<br>indications for use, the same principle of operation, and the same laser<br>parameters as the predicate device(s). |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Cynosure Smartlipo Mutliwavelength Laser is a safe and effective<br>device for the 'indications for use' specified. |
| Additional Information: | none |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected by flowing lines, representing the department's focus on health and human well-being. The logo is presented in black and white.

Public Health Service

JAN 31 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynosure, Inc. % Mr. George Cho Senior Vice President, Medical Technology 5 Carlisle Road Westford, Massachusetts 01886

Re: K080121 Trade/Device Name: Cynosure Smartlipo Multiwavelength Laser Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 16, 2008 Received: January 17, 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

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Page 2 - Mr. George Cho

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 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 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):

Cynosure Smartlipo Multiwavelength Laser Device Name:

Indications For Use:

The Cynosure Smartlipo Multiwavelength 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 Multiwavelength 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off

Division of General, Restorative, and Neurological Devices

Number L050121