CYNOSURE SMARTLIPO MPX LASER

K083795 · Cynosure, Inc. · GEX · Jan 21, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083795
• Device Name: CYNOSURE SMARTLIPO MPX LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 21, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Nd:YAG laser system (1064 nm and 1320 nm wavelengths) utilizing SmartSense T Module; footswitch-activated; used for surgical soft tissue procedures and laser-assisted lipolysis. Operated by clinicians in surgical settings. Laser energy delivered to target tissue to perform incision, excision, vaporization, ablation, or coagulation. Benefits include precise tissue interaction for surgical and lipolysis applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser system; dual wavelength (1064 nm and 1320 nm); footswitch activation; 220 VAC, 20A, 50-60 Hz power requirement; dimensions 41"x18"x32"; weight 285 lbs.

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

• Cynosure YAG Family laser

Submission Summary (Full Text)

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| | Submitter | Cynosure, Inc<br>5 Carlisle Road<br>Westford, MA 01886 | JAN 21 2009<br>K083795 |
|--|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Contact | George Cho<br>Senior Vice President of Medical Technology | |
| | Date Summary Prepared | December 19, 2008 | |
| | Device Trade Name | Cynosure Smartlipo MPX Laser | |
| | 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 MPX laser with SmartSense T Module is a<br>Nd YAG laser, having a ND YAG crystal rod as a lasing medium It<br>is a laser with a 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 MPX Laser is intended for the surgical incision,<br>excision, vaporization, ablation, and coagulation of soft tissue Soft<br>tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and<br>smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph<br>vessels and nodes, organs and glands The SmartLipo is further<br>indicated for laser assisted lipolysis | |
| | Comparison | The Cynosure Smartlipo MPX Laser with SmartSense T Module has<br>the same indications for use, the same principle of operation, and the<br>same laser parameters as the predicate device(s) | |
| | Nonclinical Performance Data | none | |
| | Clinical Performance Data | none | |
| | Conclusion | The Cynosure Smartlipo MPX Laser with SmartSense T Module is a<br>safe and effective device for the 'indications for use' specified | |
| | Additional Information | none | |

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Image /page/1/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2009

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

Re K083795

Trade/Device Name Cynosure Smarthpo MPX Laser with SmartSense T 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 December 19, 2008 Received December 22, 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, lusting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration

If your device is classified (see above) into ether class II (Special Controls) or class III (PMA), t 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 Complance 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 B1ometric'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 Surveyllance 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 M. Milburn

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 MPX Laser with SmartSense T Module Device Name

Indications For Use

The Cynosure Smartlıpo 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, cartılage meniscus. mucous membrane, lymph vessels and nodes, organs and glands The Cynosure Smartlıpo MPX Laser is futher ındıcated for laser assısted lıpolysis

Prescriptive Use X 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)

Daind Krone for MXM 1/21/2009

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

**510(k) Number** K083795