Sy-neron - Food and Drug Administration

1 Sy-neronreet'Th' tti C bh Con'510(K) Summary of Safety and Effectiveness NOV -9 2010 This summary of safety and effectiveness information is being submitted in accordance withthe requirements of the SMDA 1990 and 21 CFR name: syneron Medical Ltd.,Industrial Park, 550 Yokneamn Illit, 20692, IsraelContact Person: Avi HirshnzonVP of QIA and Regulatory AffairsTel: + 972 54 330 3402, + 972 732 442 200, Ext. 254 Fax: + 972 732 442 202E-mail : avih~ Name: eMatrix 002 Common name: C02 laser systemClassification: Name: powered laser surgical instrumentProduct Code: GEXR egulation No: : 11 Classification Panel: General & Plastic SurgeryPredicate devices : Substantial equivalence to the following predicate devices isclaimed:1.

2 Fraxel Ill SR Laser System (Fraxel re:pairTM) and accessoriesK071 051; Reliant Alma Lasers Family of THERMO-XEL Handpieces Pixel Models:2940, 1060 K072182; Alma Lasers3. Alma Lasers THERMO-XEL C02 Laser System and DeliveryDevice Accessories K080463; Alma Lasers5-1 SyneronSpar r~im' g' wJfit~ custoe CDevice description: The eMatrix 002 is a Fractional 002 laser device intended fordermatological procedures requiring ablation, coagulation andresurfacing of soft tissue including skin. The device consolehouses the major units of the system that include the laser module,the power supply, the scanner and all other electrical is transmitted to the tissue via a series of lens integrated intothe articulated arm.

3 The system parameters are controlled via aLCD touchscreen and proprietary for Use Dermatological procedures requiring ablation, coagulation andStatement: resurfacing of soft tissue, including Evaluation of skin biopsies revealed morphological changes, whichvalidation: were created under the impact of the eMatrix 002 of skinresurfacing, as expressed via demarcated zones of ablation andcoagulation. The different treatment modes led to a different impactin depth and width of the tissue. The affected zones tended tobecome deeper as the level of energy employed was affected zone were of uniform fractional phenotype, leavingintact, non-affected tissue between treated.

4 We have demonstrated that the eMatrix C02 meets its labeledperformance claims, and that it is substantially equivalent to thepredicate devicesb >040 Date HQA&Regulatory AffairsSyneron Medical OF HEALTH & HUMAN SERVICES Pu~blic H4ealth Service47Z food and drug Administration1 0903 Newv FI ampshire AvenueIDocument Contr ol Roomn --W066-G609 SilIver Spring. NID 20993-0002 syneron Medical Mr. Avi HirshnzonVP Quality Assurance and RegulatoryIndustrial Zone, Tavor Building NOV -9 21 Yokneamn Ihut Box 550, IsraelRe: K101321 Trade/Device Name: eMatrix C02 Regulation Number: 21 CFR 10 Regulation Name: Laser surgical instrument for use in general andplastic surgery and in dermatologyRegulatory Class: Class IIProduct Code: GEXD ated: November 04, 20 10 Received: November 05, 2010 Dear Mr.

5 Hirshnzon:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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 prernarket approval application(PMA).

6 You may, therefore, market the device, subject to the general controls provisions of theAct. The general controls provisions of the Act include requirements for annual registration,listing of devices , good manufacturing practice, labeling, and prohibitions against misbrandingand adulteration. Please note: CDRFI does not evaluate information related to contract liabilitywarranties. We remind you; however, that device labeling must be truthful and not your device is classified (see above) into either class 1I (Special Controls) or class III (PMA), itmay be subject to additional controls.

7 Existing major regulations affecting your device'can befound in the Code of Federal Regulations, Title 21, Pants 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal 2 -Mr. Avi l-lirshinzonPlease be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has niade a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21 CER Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act).

8 21 CFR you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to forthe Center for devices and Radiological Health's (CDRH's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification' (21 ICFR ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go for the CDRFIl's Off-iceof Surveillance and Biometrics/Division of Postmarket may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number.

9 (800) 638-2041 or (301) 796-7100 or at its Internet gov/MedicalDevices/ResourcesforYou/1 yours,Mark N. MelkersonDirectorDivision of Surgical, OrthopedicAnd Restorative DevicesOffice of Device EvaluationCenter for devices andRadiological HealthEnclosureIndications for UseNOV -9 2010510(k) Number: .03 Device Name: eMatrix 002 Indications for Use:Dermatological procedures requiring ablation, coagulation and resurfacing ofsoft tissue, including Use ___x__ AND/OROver-The-Counter Use ____(Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)Cocto (ODE)and Restorative Devices5 10(k) Nu mber <~aIS