Magma Spark

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 9, 2016 Formatk Systems Ltd. % Ahava Stein Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 IL Re: K162781 Trade/Device Name: Magma Spark 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: September 29, 2016 Received: October 3, 2016 Dear Ahava Stein: 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Center for Devices and Radiological Health Office of Device Evaluation Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162781 Device Name Magma Spark #### Indications for Use (Describe) Magma Spark device is indicated for use in aesthetic applications in dermatology. Magma Spark device has connection capability with the follo\ving available treatment hand-pieces (applicators), for multiapplication treatment options. All hand-pieces are designed for aesthetic demlatologic procedure applications. Magma Spark device \vith ALD or LLD diode laser applicators is indicated for hair removal, pennanent hair reduction* in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB). (*Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime) Type of Use (Select one or both, as applicable) |ZJ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 6: Special 510(k) Summary ### 510(K) SUMMARY # MAGMA SPARK DEVICE 510(k) Number K162781 | Applicant Name: | Formatk Systems Ltd | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Company Name: | Tavor Building, POB 533<br>Yokneam Iillit 2069206 Israel<br>Tel: +972-4-909-7440<br>Fax: +972-4-909-7471<br>E-mail: ahava@asteinrac.com | | Contact Person:<br>Official Correspondent: | Ahava Stein | | Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. | | Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 4442520 Israel<br>Tel: + 972-9-7670002<br>Fax: +972-9-7668534<br>E-mail: ahava@asteinrac.com | | Date Prepared: | September 29, 2016 | | Trade Name: | Magma Spark | | Classification Name: | CFR Classification section 878.4810 (Product code GEX) | | Classification: | Class II Medical Device | Predicate Device: Magma Spark device is substantially equivalent to the previously cleared, Magma device, also manufactured by Formatk Systems Ltd. | Device | Manufacturer | 510(k) No. | |--------|----------------------|------------| | Magma | Formatk Systems Ltd. | K153566 | {4}------------------------------------------------ Device Description: The Magma Spark device is a computerized multi-application platform intended for non-invasive aesthetic applications utilizing laser optical power. Magma Spark is a relatively small tabletop device that provided with melanin meter and two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including an LCD display and touch screen module. The operator of Magma Spark chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device. | Main Line Frequency (nominal) | 50 - 60 Hz | | |---------------------------------------|--------------------------|--| | Input Voltage (nominal) | 100 - 240 VAC | | | Input Current (A) | 6.0 max | | | Platform dimensions (inch) | 26.0"W x 21.7"D x 23.6"H | | | Platform weight (lb.) | 50.7 | | | ALD & LLD Diode laser wavelength (nm) | 808 | | | Maximal Fluence (J/cm2): | | | | ALD | Up to 75 | | | LLD | Up to 35 | | Device Specifications: Intended Use/Indication for Use: Magma Spark device is indicated for use in aesthetic and cosmetic applications in dermatology. Magma Spark device has connection capability with the following available treatment hand-pieces (applicators), for multi-application treatment options. All handpieces are designed for aesthetic and cosmetic dermatologic procedure applications. Magma Spark device with ALD and LLD diode laser applicators iis indicated for hair removal, permanent hair reduction in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB). Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completions of treatment regime {5}------------------------------------------------ Section 6: Special 510(k) Summary Performance Standards: Magma Spark complies with the following recognized consensus standards: - . AAMI/ANSI 60601-1 (2012). Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod). - . IEC 60601-1-2 (Edition 3.0, 2007), Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. - . IEC 60825-1 (Edition 2.0, 2007), Safety Of Laser Products - Part 1: Equipment Classification, And Requirements JIncluding: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]. - . IEC 60601-2-22 (Edition 3.0, 2007 & Edition 3.1 2012), Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment. Non-Clinical (Bench) Performance Data: The underlying technology and principle of operation of Magma Spark is essential the same as the predicate device. Therefore, results were gathered to support the safety of the modified device and thorough test of the software was executed. Comprehensive software-system test plan and results report covers the full system test of the Magma Spark. It includes operation and user procedures, as well as programs. In addition to comprehensively testing firmware functionality, hardware interfaces, performance, load test, download procedure, integrity, recovery and usability. Pre-Clinical (Animal Study) Performance Data: Not Applicable Clinical Performance Data: Not Applicable ## Substantial Equivalence: The components of modified Magma Spark device, similarly to predicate Magma device, generate its mechanism of operation using the same underlying technology. Delivery of the laser energy through each specific applicator (either ALD or LLD) is monitored and controlled by the device's CPU. The user interface control panel {6}------------------------------------------------ provides the user with the optimal treatment settings taking into consideration the patient skin type and hair type (for hair removal treatments). Since Magma Spark device is limited to operate with diode laser applicators only, the intended use of Magma Spark device is same as predicate Magma device in relation to the diode laser-relevant applications only. Using both modified and cleared devices the device user can decide on the optimal treatment settings and adjust these treatment settings through the control panel. Furthermore, Magma Spark device, as the cleared Magma device, introduces similar safety features and comply with same relevant consensus standards. ### Conclusions: Based on the comparison to predicate device, Magma Spark device is substantially equivalent to the predicate Magma device for the mentioned indication for use.