MULTIWAVE XR

{0}------------------------------------------------ 10. APPENDIXES phone 1-(805)-640-8080 fax 1-(805)-640-8081 ## SEP - 9 2005 # 10.1. K051876 ## Appendix A (510(k) Summary) ### 510(k) Summary In accordance with the Safe Medical Devices Act of 1990, 21CFR 807.92, the following is a summary of the safety and effectiveness information on which the substantial equivalence determination is based. The safety and effectiveness of the MultiWave XR laser system derives from a determination of substantial equivalence to the predicated devices listed below. Pacific Quantum Instruments, Inc. Applicant 408 Bryant Circle, Suite F-1, Ojai, CA 93023 Address Gennady L. Nikolaenko, Ph.D., President & CEO Contact Person (805)-640-8080 Telephone (805)-640-8081 Fax nikolaenko@mailnew.com E-mail MultiWave XR Device Trade Name Medical Laser System Common Name Laser surgical instrument for use in general and plastic surgery and Classification Name dermatology (21 CFR 878.4810), Class II Product Code: GEX -- Laser, instrument, surgical, powered Panel: 79 1). GentleYAG (Candela), K022951, K023193 Predicate Devices 2). GentleLASE GL (Candela), K994260 3). Gemini (Laserscope), K034011 4). Aura i (Laserscope), K024206 5). Apogee Elite (Cynosure), K034030 6). Adept 1064/532/755 Laser (Adept Medical Concepts) K032218 The MultiWave XR combines three laser outputs in a single device. Device Description It produces a long pulse laser light of 532 nm, 755 nm, and 1064 nm wavelengths. The laser head has two optical cavities containing an Alexandrite crystal rod (755 nm) and a Nd:YAG crystal rod (1064 nm) with optional frequency doubler installed (532 nm). Pulsed laser energy accomplished with a red aiming beam of low energy (5mW, 635nm) is delivered to a target via an optical fiber and a handpiece. Each laser outlet has own fiber and handpiece. Chilled air is delivered to the same target via jets in a handpiece. The MultiWave XR laser system is indicated for permanent hair Intended Use removal, for treatment of vascular lesions, pigmented lesions, and wrinkles {1}------------------------------------------------ #### Appendix B (Summary of Substantial Equivalence) 10.2. ## Summary of Substantial Equivalence Pacific Quantum Instrument, Inc. believes that its MultiWave XR laser system is substantially equivalent: - a) regarding all three available in MultiWave XR laser emissions together (1064 nm, 755 nm and 532 nm), to the legally marketed device: Adept 1064/532/755 Laser (Adept Medical Concepts, Inc., K032218); - b) regarding 1064 nm laser emission, to the following legally marketed devices: 10Eaut 1064/532/755 Laser (K032218), GentleYAG (Candela, K022951), Gemini (Laserscope, K034011), Apogee Elite (Cynosure, K034030); - c) regarding 755 nm laser emission, to the following legally marketed devices: regarding 195 ml/7 asser (K032218), GentleLASE GL (Candela, K994260), Apogee Elite (Cynosure, K034030); - d) regarding 532 nm laser emission, to the following legally marketed devices: Adent 1064/532/755 Laser (K032218), Gemini (Laserscope, K034011), Aura i (Laserscope, K024206). All these predicate devices previously cleared for medical applications, which include all Indications for Use of MultiWave XR proposed by Pacific Quantum Instruments, Inc. in the Indications for Use Statement (see Appendix 10.3) Technologically, the predicate devices have identical characteristics to the MultiWave XR I connotegrounly, all comprising a flash lamp pumped Nd:Y AG laser rod generating light at 1064 iaser System, an onsperised Alexandrite laser rod generating light at 755 nm, which is subsequently delivered to the patient via individual optical fiber delivery system and focusing handpiece. Moreover, all lasers are microprocessor controlled devices with internal closed water-air laser cooling system, and Class I, 635 nm, aiming pilot lasers, which pose no hazard to the user. The risk and benefits of the MultiWave XR laser system are comparable to the predicate devices when used for similar applications. It is therefore believed that there are no NEW questions of Safety and Effectiveness raised by the introduction of this device: MultiWave XR laser system. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white. SEP - 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Gennady L. Nikolaenko, Ph.D. President and CEO Pacific Quantum Instruments, Inc. 408 Brvant Circle, Suite F-1 Ojai, California 93023 Re: K051876 Trade/Device Name: MultiWave XR 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: July 6, 2005 Received: July 11, 2005 Dear Dr. Nikolaenko: 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. {3}------------------------------------------------ ## Page 2- Gennady L. Nikolaenko, Ph.D. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ought interest of your device of your device to a legally premaired 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 in you t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, eonater and other of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic 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, Neil R. Snyder Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Appendix C (Indications for Use Statement) 10.3. ### Indications for Use Statement 510(k) number: K 0.51876 Device name: MultiWave XR Indications for use: The MultiWave XR Laser System is indicated for the following uses: - 1. The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face. - 2. The 755 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for I-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. - 3. The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction. V Prescription Use (Part 21 CFR 801 Subpart D) and/or Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neilke Bl **(Division Sign-Off)** - for mman Division of General, Restorative, and Neurological Devices 510(k) Number K051876