LIPOEZE LASER ASSISTED ASPIRATION CANNULA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K691800". The handwriting is somewhat stylized, with some characters connected and others distinct. The overall impression is that of a quickly written or informal note. Image /page/0/Picture/1 description: The image shows the logo for MEDICEPT, a company that specializes in medical instruments. The logo is in black and white, with the company name in bold letters. Below the company name is the tagline "Unique Concepts In Medical Instruments". The logo is simple and professional, and it conveys the company's focus on medical instruments. SEP 2 3 2009 Handpiece Accessory Curve Medical, Inc. MEDIcept. Inc. 200 Homer Ave Ashland, MA 01721 F. David Rothkopf 508-231-8842 x20 508-231-8861 Fax 2621 Newton Ave South Minneapolis, MN 55405 Registration: (awaiting number) Class II LipoEze Laser Assisted Aspiration Cannula LipoEze Laser Assisted Aspiration Cannula ## Attachment III ### 8.0 Executive Summary Curve Medical is requesting marketing clearance for a cannula. Trade Name: Device Name: Common Name: Classification: Manufacturer/Sponsor: Consultant/Contact: Primary Contact: Product Codes: Device Classification: Classification Panel: 878.4810, Powered Laser Surgical Instrument GEX, Powered Laser Surgical Instrument General & Plastic Surgery #### Predicates: K933017, Sunrise Technologies Model 5030 Suction Handpiece System 878.4810, GEX, Powered Laser Surgical Instrument, Class II K073617 Osyris: PHARAON LIPO 878.4810, GEX, Powered Laser Surgical Instrument, Class II LipoEze Cannula {1}------------------------------------------------ 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 stylized depiction of a human figure, represented by three curved lines, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the figure. SEP 2 3 2009 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Curve Medical % MEDIcept Mr. F. David Rothkopf President 200 Homer Avenue Ashland, Massachusetts 01721 Re: K091800 Trade/Device Name: LipoEze Cannula Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 16, 2009 Received: September 18, 2009 ### Dear Mr. Rothkopf: 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 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 {2}------------------------------------------------ Page 2 - Mr. F. David Rothkopf CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 yours. cerely yours, pe Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for "MEDICEPT" in a stylized font. Below the logo, the text "Unique Concepts In Medical Instruments" is printed in a smaller, simpler font. The logo and text are black against a white background. Attachment II # Indications for Use 510(k) Number (if known): K091800 Device Name: LipoEze Cannula Indications for Use: The LipoEze Cannula is a suction hand piece intended for use with a 980nm laser fiberoptic delivery system during laser assisted lipolysis. # Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use __ 21CFR 801.109 ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) ### Concurrence of CDRH, Office of Device Evaluation (ODE) Nil REEgle for mxm (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K091800 Curve Medical Traditional 510(k) Response September 16, 2009 LipoEze Cannula