SMARTEPIL,DEPILASE YAG LASE PLUS

{0}------------------------------------------------ KII 2141 Page 1 of 2 APR 1 3 2012 ### 510(k) Summary #### Castle Laser Systems Limited #### Submitter's Contact Information | Name: | Raymond R. Blanche | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Address | NST Consulting, LLC<br>641 Shunpike Road, Suite 311<br>Chatham, New Jersey, 07928 | | Telephone:<br>Facsimile: | (973) 539-7444<br>(973) 539-7445 | | Name of Device and Name/Address of Sponsor | | | Trade Name: | CLS001 Laser System | | Sponsor Contact<br>Information: | David Smith<br>Castle Lasers Systems Limited<br>64 Dudley Street<br>Bedford<br>Bedfordshire, MK40 3TB<br>United Kingdom | | Common or Usual Name: | Medical Laser System | | Classification Name: | Instrument, surgical, powered, laser<br>79-GEX<br>21 CFR 878.48 | #### Predicate Devices: #### Device Trade Name 1 Sinch ## Manufacturer Smartepil Depilase Yag Lase Plus Cynosure, Inc. Depilase Group Ltd Date Prepared: July 15, 2011 Updated April 12, 2012 · · {1}------------------------------------------------ #### Intended Use / Indications for Use The CLS001 Laser System is indicated to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI; including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types. #### Technological Characteristics The CLS001 Laser System is an analog, pulsed Nd: YAG laser utilizing the Nd: YAG crystal as the lasing medium. It operates at the wavelength of 1064 nanometers. Laser activation is controlled by a footswitch mechanism. Physically, the system weighs 66 pounds, is 13.8 inches high, 23.6 inches wide and 17.3 inches deep. The electrical requirements are 220/240 VAC single phase, 50/60 Hz and 8 amps. # Performance Data: Clinical Performance Data: none required Non-clinical Performance Data: Manufactured according to cGMP per Guide to CGMP, WHO/VSQ/97.02 # Substantial Equivalence ' ' ' ' ' The CLS001 Laser System is as safe and effective as the other devices in its class, the Smartepil and the Depilase. The sponsor believes that with the exception of the configuration of the predicate devices, the devices are identical in the key areas that effect safety and efficacy. Both The sponsor believes that the difference in the physical appearance or in the method of delivering the radiant energy of the device systems is of no consequence and does not effect the therapeutic value or the safety profile. The sponsor believes that the difference between the devices is limited to the method of controls. The CLS001 is an analog system and the predicate devices are digital, microprocessor controlled systems. The CLS001 laser system is another safe and effective Nd: YAG laser intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI. including suntanned skin types. Therefore, the CLS001 Laser System satisfies the FDA's substantial equivalence criteria and should be granted a 510(k) clearance for marketing. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Castle Laser Systems, LTD % NST Consulting, LLC Mr. Raymond R. Blanche Managing Member 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928 APR 1 3 2012 Re: K112141 Trade/Device Name: Caste Laser Long Pulse Nd: YAG CLS001 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: February 28, 2012 Received: March 7, 2012 Dear Mr. Blanche: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 r hat 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ #### Page 2 - Mr. Raymond R. Blanche 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours, Eunice Keith - Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### INDICATIONS FOR USE 510(k) Number: k 112141 Device Name: Castle Laser Long Pulse Nd:YAG Laser CLS001 Indications for Use: The CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED) Concurrence of CDRH, Office of device Evaluation (ODE) Prescription Use __ X (Part 21 CFR 801 Subpart D) OR Over-the -Counter Use Neilkohl for mxn (Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112141 Premarket Notification for the Castle Laser System CLS001