LONG PULSE ND: YAG LASER SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 8, 2014 Advanced Technology Laser Company, Ltd % Ms. Diana Hong Mid-Link Consulting Company, Ltd P.O. Box 120-119 Shanghai, 200120 CHINA Re: K140249 Trade/Device Name: Long Pulse Nd:YAG Laser System 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 5, 2014 Received: September 8, 2014 Dear Ms. Hong: 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 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); medical device reporting (reporting of medical {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Binita S. Ashar -S 2014.10.08 12:44:48 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K140249 Device Name Long Pulse Nd: Y AG Laser System #### Indications for Use (Describe) Long pulse Nd: Y AG Laser System is intended for use for : · Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques. • Pigmented lesions to reduce lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. · Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. #### Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### Section 3 510(k) Summary This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K140249 - 1. Date of Submission: 09/10/2014 - Sponsor Identification 2. Advanced Technology Laser Co., Ltd. 920 Jian-chuan Road, Bldg. A2, Level 5,Shanghai, 200240, China Establishment Registration Number: 3007604279; Contact Person: Mingxia Xi Position: Regulator Affair Director Tel: +86-21-5471 2151 Fax: +86-21-5471 2152 Email: xmx@at-laser.com - 3. Submission Correspondent Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net {4}------------------------------------------------ - Proposed Device Identification 4. Trade Name: Long Pulse Nd: YAG Laser System; Common Name: Nd:YAG Dermatology Laser System; Model: SmoothTouch; Regulatory Information: Classification Name: Powered Laser Surgical Instrument; Classification: II; Product Code: GEX; Regulation Number: 21CFR 878.4810; Review Panel: Laser Instrument, Surgical, Powered; Intended Use Statement: Long pulse Nd:YAG Laser System is intended for use for : - Benign pigmented lesions such as ,but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques. - . Pigmented lesions to reduce lesion size, for patients with lesions that would potientlly benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part . of the scar. - Predicate Device Identification ર. 510(k) Number: K022923 Product Name: Gentle YAG Laser System Manufacturer: Candela Corporation - 6. Device Description The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues. {5}------------------------------------------------ Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins. Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features - 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1:2005, Medical Electrical Equipment - Part 1: General requirements for safety. IEC60601-1-2:2007, Medical Electrical Equipment - Part 1: General requirements for safety - 2, Collateral Standard: Electromagnetic compatibility - Requirements and tests. IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment. IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements {6}------------------------------------------------ Section 3 510 Summary #### 8. Substantially Equivalent (SE) Conclusion The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc. | Item | Proposed Device(s) | Predicate Device | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Product Code | GEX | GEX | | Regulation Number | 21CFR 878.4810 | 21CFR 878.4810 | | Intended Use | Long pulse Nd:YAG Laser System is intended for use for :<br>Benign pigmented lesions such as ,but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.<br>Pigmented lesions to reduce lesion size, for patients with lesions that would potientlly benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.<br>Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. | SAME | | Energy Source | ND:YAG Laser | SAME | | Waveform | 1064 nm | SAME | | Fluence energy range | up to 600J/cm2 | SAME | | Spot size | 1.5mm, 3mm, 8mm, 10mm, 12mm and 3mm*8mm | SIMILAR | | Aiming laser | 510nm diode laser (<5mW), Class III | SIMILAR | | Beam Delivery | Permanently attached umbilical cable and handpieces | SAME | Table 3-1 Comparison of Technology Characteristics The proposed device, Long Pulse Nd:YAG Laser System, is determined to be Substantially Equivalent (SE) to the predicate device, Gentle YAG Laser System, in respect of safety and effectiveness.