MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523

{0}------------------------------------------------ ### 510(k) Summary or 510(k) Statement 5. Medite C6 Q-Switched Nd: YAG Laser Medlite Compression Tool and Handpiece Attachment Accessories 510k Summary Image /page/0/Picture/4 description: The image shows the logo for HOYA ConBio. Below the logo is the address 47733 Fremont Boulevard, Fremont, California 94538. The address is printed in a smaller font than the logo. 510-445-4500 www.conbio.com 510-445-4550 Fax K060977 | Submitter: | Hoya ConBio, Inc.<br>47733 Fremont Blvd.<br>Fremont, California 94538<br>Phone: 510-445-4500<br>Fax: 510-445-4550 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Mr. Jim Green<br>Vice President of Engineering | | Date Summary Prepared: | March 28, 2006 | | Device Trade Name: | Medlite ^™ Nd: YAG Laser System: Compression Tool and<br>Handpiece Accessory | | Common Name: | Dermatology Laser System | | Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.4810 | | Equivalent Device: | Candela Pigmented Lesion Compression Handpiece<br>Accessory - K051359<br>Medlite ^™ C6 Q-Switched Nd: YAG Laser / Standard<br>MultiSpot ^™ Handpiece Accessory - K014234 | | Device Description: | The Compression Tool and Handpiece Attachment<br>Accessories are intended to be used to assist and enhance<br>the procedure of treating dermatological conditions The<br>Compression Tool and Handpiece Attachment Accessories<br>are additional accessories designed to accompany the<br>currently offered MedLite MultiSpot Handpiece. The<br>purpose for these accessories are purely for a cosmetic end<br>to help reduce undesirable purpura while treating with the<br>Medlite C Series lasers. | | Intended Use: | For use in dermatology for all currently approved indications<br>for the Medlite C-Series Nd: YAG Laser Systems and<br>MultiSpot Handpiece. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it consists of a staff with two snakes coiled around it and wings at the top. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA". ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 4 2006 Hoya ConBio™ % Mr. Jim Green Vice President of Engineering 47733 Fremont Boulevard Fremont, California 94538 Re: K060977 Trade/Device Name: HOYA ConBio Compression Tool and Handpiece Accessories for use with MedLite™ C Series Q-Switched Nd: YAG Laser Systems 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: April 6, 2006 Received: April 10, 2006 Dear Mr. Green: 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 {2}------------------------------------------------ ## Page 2 - Mr. Jim Green 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. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use Statement 4. # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: HOYA ConBio Compression Tool and Handpiece Accessories for use with the MedLite™ C Series Q- Switched Nd: YAG Laser Systems. Indications for Use: Tattoo Removal Nevus of Ota Hair Removal Vascular Lesions Dermal Pigmented Lesions Epidermal Pigmented Lesions Laser Resurfacing for Acne scars and wrinkles Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (Division Sign-Villancurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices Page of (Posted November 13, 2003) 510(k) Number_koso977 Page 15 of 83