← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K083379 # CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE (K083379) _Cynosure, Inc. · GEX · Dec 12, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K083379 ## Device Facts - **Applicant:** Cynosure, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Dec 12, 2008 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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". ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Submitter: Contact: Date Summary Prepared: Device Trade Name: Common Name: Classification Name: Equivalent Device: Device Description: Intended Use: Comparison: Nonclinical Performance Data: Clinical Performance Data: Conclusion: Additional Information: ## 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 {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. #### 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. {2}------------------------------------------------ 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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 {3}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K083379](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K083379) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com