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GEX

2,872 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
CALCULASE II (K140964)KARL STORZ Endoscopy-America, Inc.2014-09-04+ Add
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM (K140009)Alma Lasers , Ltd.2014-08-29+ Add
DIOTECH LASER FIBER (K140458)Diotech CO2014-08-26+ Add
ENDLESSFIBER REUSABLE SURGICAL LASER FIBER (K140366)Hogue Surgical, LLC2014-08-15+ Add
CUTERA PICOSECOND LASER SYSTEM (K133945)Cutera, Inc.2014-08-11+ Add
NEUROBLATE SYSTEM (K141983)Monteris Medical Corp.2014-08-11+ Add
LITHO (K141101)Quanta System Spa2014-08-08+ Add
LITHO DK30 (K141403)Quanta System Spa2014-08-07+ Add
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) (K141838)Regulatory Technology Services, LLC2014-07-25+ Add
PICOSURE WORKSTATION (K133364)Cynosure, Inc.2014-07-22+ Add
ALMA DIODE TABLETOP LASER (K140005)Alma Lasers , Ltd.2014-07-18+ Add
TATTOOSTAR EFFECT COMBO (K131757)Asclepion Laser Technologies GmbH2014-07-17+ Add
LINSCAN 808, LINSCAN 980 (K141063)Gme (German Medical Engineering) GmbH2014-07-15+ Add
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE (K132806)Fotona D.D.2014-07-11+ Add
SUREFLEX LITHOTRIPSY LASER FIBERS (K140679)American Medical Systems2014-06-20+ Add
QUADROSTARPROGREEN, QUADROSTARPROYELLOW (K133297)Asclepion Laser Technologies GmbH2014-06-10+ Add
ATOVEN (K133774)Bio-Med USA, Inc.2014-06-06+ Add
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM (K140122)Candela Corp.2014-05-09+ Add
DIODE LASER FOR HIAR REMOVAL (K131838)Beijing Honkon Technologies Co., Ltd.2014-04-24+ Add
GALAXY CO2 LASER SYSTEM (K133915)Beijing Toplaser Technology Co., Ltd.2014-04-18+ Add
NEOV DIODE LASER FAMILY (K133006)G.N.S Neolaser , Ltd.2014-04-17+ Add
ADVATX (K132976)Advalight Aps2014-04-17+ Add
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER (K140503)Boston Scientific2014-04-15+ Add
VIORA V-TOTAL (K133837)Viora , Ltd.2014-04-09+ Add
NS 2500 HOLMIUM LASER SYSTEM (K132607)New Star Lasers, Inc.2014-03-21+ Add
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 (K133319)Lumenis, Ltd.2014-03-20+ Add
SPHINX JR (K132975)Allmed Systems, Inc.2014-03-18+ Add
LUMENIS PULSE 120H (K140388)Lumenis, Ltd.2014-03-14+ Add
NOVEON (K122358)Hogan Lovells US LLP2014-03-11+ Add
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM (K133254)Cynosure, Inc.2014-03-05+ Add
ND: YAG LASER SYSTEM (K133158)Beijing Toplaser Technology Co., Ltd.2014-02-28+ Add
SPEED 808 DIODE LASER SYSTEM (K132989)Beijing Toplaser Technology Co., Ltd.2014-01-23+ Add
HYPERION LONG PULSED ND: YAG LASER (K132286)Scarlet Rf, Inc.2014-01-22+ Add
CO2 FRACTIONAL LASER (K131837)Beijing Honkon Technologies Co., Ltd.2014-01-22+ Add
Q-SWITCHED ND:YAG LASER (K131857)Beijing Honkon Technologies Co., Ltd.2014-01-16+ Add
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER (K130681)Biolitec Sia2014-01-08+ Add
LIGHTSCALPEL (K132661)Lightscalpel, LLC2014-01-02+ Add
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS (K133283)Candela Corp.2013-12-26+ Add
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH (K133561)AngioDynamics, Inc.2013-12-19+ Add
FAMILY OF COOLGLIDE AESTHETIC LASERS (K132185)Cutera, Inc.2013-12-06+ Add
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS (K131095)El.En Electronic Engineering Spa2013-12-05+ Add
GENESIS LED WANDS (K131142)Genesis Biosystems, Inc.2013-11-27+ Add
CLARITY LPC LASER SYSTEM (K130199)Lutronic Corporation2013-11-22+ Add
DC 7 (K131839)Dc International, LLC2013-11-07+ Add
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K131894)Nidek Co., Ltd.2013-10-31+ Add
(QUANTA SYSTEM) SURGICAL LASER FIBERS (K131473)Quanta System Spa2013-10-24+ Add
PIONEER ELITE DIODE LASER (K131059)CAO Group, Inc.2013-09-13+ Add
PRECISE SHP DIODE LASER (K123443)CAO Group, Inc.2013-08-13+ Add
NEUROBLATE(TM) SYSTEM (K131955)Monteris Medical, Inc.2013-07-30+ Add
INPULSE LASER (K131805)Incisive, Inc.2013-07-18+ Add
SOLEA (K130420)Convergent Dental, Inc.2013-07-12+ Add
MONTERIS MEDICAL NEUROBLATE SYSTEM (K131278)Monteris Medical, Inc.2013-07-11+ Add
CYBER TM FAMILY (K131081)Quanta System Spa2013-07-03+ Add
MDK MULTI-APPLICATIONS PLATFORM (K130256)Quanta System Spa2013-07-02+ Add
COOK HOLMIUM LASER FIBER (K124030)Cook Incorporated2013-07-01+ Add
JOULE 810/940/980 MULTI-PLATFORM SYSTEM (K122567)Sciton, Inc2013-06-19+ Add
FRAXEL DUAL 1550/1927 LASER SYSTEM (K130193)Solta Medical, Inc.2013-06-14+ Add
PHOTON PHOTON PLUS (K122020)Zolar Technology & Mfg Co., Inc.2013-06-05+ Add
H-30 HOLMIUM LASER SYSTEM (K130444)Cook, Inc.2013-05-22+ Add
GENESISPLUS (K122493)Cutera, Inc.2013-05-15+ Add
QYAG LASER SYSTEM (K130250)Palomar Medical Technologies, Inc.2013-05-03+ Add
WATERLASE IPLUS ALL TISSUE LASER (K122368)Biolase Technology, Inc.2013-05-02+ Add
DIODE LASER (K123483)BEIJING SYNTECH LASER CO., LTD.2013-04-21+ Add
YOULASER CO2 LASER (K123573)Quanta System Spa2013-04-15+ Add
EPIC 10S (K130465)Biolase Technology, Inc.2013-04-11+ Add
PASTELLE Q-SWITCHED ND: YAG LASER (K123293)Won Technology Co., Ltd.2013-04-11+ Add
MULTILASER SYSTEM (K123777)Ultralight Laser Technologies, LLC2013-04-11+ Add
NEUROBLATE SYSTEM (K120561)Monteris Medical, Inc.2013-04-01+ Add
VENACURE EVLT NEVERTOUCH PROCEDURE KIT (K130671)AngioDynamics, Inc.2013-03-26+ Add
FIBERLASE ENDURE CO2 FIBER (K130164)Lumenis, Ltd.2013-03-24+ Add
DORNIER MEDILAS UROPULSE (K130344)Dornier Medtech America, Inc.2013-03-21+ Add
PINPOINTE FOOTLASER (K130413)Nuvolase, Inc.2013-03-21+ Add
INMODE HAIR REMOVAL (HR) DEVICE (K123682)Inmode MD , Ltd.2013-02-27+ Add
REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 (K110941)Allmed Systems, Inc.2013-02-19+ Add
SOLEA (K123494)Convergent Dental, Inc.2013-02-11+ Add
DORNIER MEDILAS H30 SOLVO (K122159)Dornier Medtech America, Inc.2013-02-01+ Add
DEKA SMARTXIDE AND DELIVERY ACCESSORIES (K113504)El.En Electronic Engineering Spa2013-02-01+ Add
DIOLASE 10S (K121327)Biolase Technology, Inc.2013-02-01+ Add
VITRA MULTISPOT (K122251)Quantel Medical2013-01-24+ Add
MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE (K124003)Med-Fibers, Inc.2013-01-17+ Add
AURIGA QI (K121570)Starmedtec GmbH2013-01-16+ Add
MIRA LASERS (K123004)Mira Lasers, LLC2013-01-15+ Add
E-BEAM ND: YAG LASER (K122922)Eclipse Aesthetics, LLC2013-01-10+ Add
Q-PLUS T+ IPL LASER SYSTEM (K123168)Quanta System Spa2012-12-20+ Add
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM (K113018)BEIJING SYNTECH LASER CO., LTD.2012-12-14+ Add
MEDILAS H LASER FIBERS (K123385)Dornier Medtech America, Inc.2012-12-14+ Add
EMVERA DIOLUX (K123257)Emvera Technologies, Inc.2012-12-14+ Add
OPELASER PRO II AND THE OPELASER LITE II (K120932)The Yoshida Dental Mfg. Co., Ltd.2012-12-07+ Add
BWF-5 MEDICAL LASER SERIES (K123031)Litecure, LLC2012-12-03+ Add
LIGHTSCALPEL (K123037)Lightscalpel, LLC2012-11-29+ Add
TXCELL SCANNING LASER DELIVERY SYSTEM (K121475)Iridex Corp2012-11-28+ Add
PICOSURE WORKSTATION (K121346)Cynosure, Inc.2012-11-27+ Add
SMARTLUX (K120460)Medmix Co., Ltd.2012-10-01+ Add
EPIC 10 (K121286)Biolase Technology, Inc.2012-09-28+ Add
SURELASE CO2 LASER SYSTEM (K121580)Clinicon Corp.2012-09-25+ Add
MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP (K120235)Aerolase Medical Lasers, LLC2012-09-17+ Add
TRIA LASER HAIR REMOVAL SYSTEM (K120737)Tria Beauty, Inc.2012-09-13+ Add
PRECISE SHP DIODE LASER (K113472)CAO Group, Inc.2012-08-30+ Add
MEDILAS H RFID LASER FIBER (K121938)Dornier Medtech America, Inc.2012-08-01+ Add
ENDOBEAM HOLMIUM LASER FIBERS (K120926)C.R. Bard, Inc.2012-07-27+ Add
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