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GEX

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

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RecordFirmDateBuilder
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY (K032205)Radiancy (Israel) , Ltd.2003-12-11+ Add
SPECTRA PULSED DIODE LASER, MODEL DR-1 (K032846)Spectragenics, Inc.2003-12-11+ Add
MODIFICATION TO AURORA DS (K033586)Syneron Medical, Ltd.2003-12-10+ Add
CANDELA SMOOTHBEAM LASER SYSTEM (K030834)Candela Corp.2003-12-03+ Add
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM (K032735)Max Engineering , Ltd.2003-12-03+ Add
POLARIS WR (K031671)Syneron Medical, Ltd.2003-12-01+ Add
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM (K032383)Curelight, Ltd.2003-11-28+ Add
ARAMIS II DERMATOLOGICAL LASER (K032260)Quantel Medical2003-11-20+ Add
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE (K033237)Vascular Solutions, Inc.2003-11-20+ Add
CYNOSURE PHOTOGENICA SV LASER (K032539)Cynosure, Inc.2003-11-17+ Add
AURA ISURGICAL LASER SYSTEM & ACCESSORIES (K024206)Laserscope2003-11-17+ Add
PROFILE BBL SYSTEM (K032460)Sciton, Inc2003-11-13+ Add
RELIANT LASER SYSTEM (K031795)Reliant Technologies, Inc.2003-11-10+ Add
DIO-DENT 10 DENTAL DIODE LASER (K031819)Msq (M2) , Ltd.2003-10-30+ Add
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS (K033172)Candela Corp.2003-10-30+ Add
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM (K032599)Medical Laser Technologies, LLC2003-10-29+ Add
ADEPT 1064/755 LASER (K032221)Adept Medical Concepts2003-10-24+ Add
ADEPT 1064/532 LASER (K032220)Adept Medical Concepts2003-10-24+ Add
ADEPT 1064/532/755 LASER (K032218)Adept Medical Concepts2003-10-24+ Add
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 (K032703)Innovatech Surgical, Inc.2003-10-24+ Add
SPR SYSTEM (K033181)Radiancy (Israel) , Ltd.2003-10-24+ Add
INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 (K032704)Innovatech Surgical, Inc.2003-10-24+ Add
CYNOSURE PHOTOGENICA VL (K032565)Cynosure, Inc.2003-10-22+ Add
LASERSMILE (K030539)Biolase Technology, Inc.2003-10-10+ Add
CYNOSURE SMART FILE ND:YAG LASERS (K031125)Cynosure, Inc.2003-10-09+ Add
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES (K032357)Lumenis, Inc.2003-10-09+ Add
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 (K032085)Nidek, Inc.2003-10-03+ Add
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K032805)Vascular Solutions, Inc.2003-10-01+ Add
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER (K031440)Cynosure, Inc.2003-10-01+ Add
CYNOSURE SMART 2940D ER:YAG LASER (K031389)Cynosure, Inc.2003-10-01+ Add
W.O.M. LASER U100PLUS (K032023)W.O.M. World of Medicine AG2003-10-01+ Add
INTRALASE FS LASER (K031960)Intra Lase Corp.2003-09-29+ Add
CANDELA SMOOTHBEAM LASER SYSTEM (K030846)Candela Corp.2003-09-16+ Add
BLU-U, MODEL 4170 (K031805)Dusa Pharmaceuticals, Inc.2003-09-09+ Add
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS (K031954)New Star Lasers, Inc.2003-08-21+ Add
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K032204)Vascular Solutions, Inc.2003-08-20+ Add
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM (K032191)Luxsano AB2003-08-20+ Add
PITANGA (K031489)Syneron Medical, Ltd.2003-08-19+ Add
AURORA DS (K031988)Syneron Medical, Ltd.2003-08-01+ Add
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 (K031451)Photo Medex, Inc.2003-08-01+ Add
AURORA SR (K031993)Syneron Medical, Ltd.2003-08-01+ Add
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES (K030033)Lumenis, Ltd.2003-07-21+ Add
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS (K030342)Lumenis, Ltd.2003-07-17+ Add
OMNILUX RED (K030426)Photo Therapeutics Limited2003-07-17+ Add
CYNOSURE PHOTOLIGHT PL (K031258)Cynosure, Inc.2003-07-08+ Add
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) (K031690)Cynosure, Inc.2003-07-08+ Add
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM (K024204)Fotona D.D.2003-07-07+ Add
SPECTRAPULSE (K031680)Primary Technology, LLC2003-06-24+ Add
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 (K024259)New Star Lasers, Inc.2003-06-20+ Add
NLITE SYSTEM, MODEL#: A00-1025/A00-1033 (K024189)Icn Photonics , Ltd.2003-06-20+ Add
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS (K024093)Lumenis, Ltd.2003-06-19+ Add
SKINSTATION (K030897)Radiancy (Israel) , Ltd.2003-06-19+ Add
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K030654)Vascular Solutions, Inc.2003-06-18+ Add
OMNILUX BLUE (K030883)Photo Therapeutics Limited2003-06-18+ Add
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT (K031233)AngioDynamics, Inc.2003-06-18+ Add
PROFILE 1064 LASER SYSTEM (K023881)Sciton, Inc2003-06-13+ Add
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER (K031488)Cynosure, Inc.2003-06-04+ Add
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT (K030700)Biolitec, Inc.2003-06-04+ Add
SMART 2940 D ER: YAG LASER (K031317)Cynosure, Inc.2003-05-22+ Add
COOL TOUCH 3 (K031184)New Star Lasers, Inc.2003-05-21+ Add
MYTHOS 500 (K030805)Msq (M2) , Ltd.2003-05-21+ Add
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS (K030527)Lumenis2003-05-20+ Add
DEPILASE TRIO LASE LASER SYSTEM (K030508)Depilase Group , Ltd.2003-05-20+ Add
DEPILASE TWIN YAG LASER SYSTEM (K030510)Depilase Group , Ltd.2003-05-14+ Add
L600 HAIR REMOVAL (K030480)A&M Technology2003-05-14+ Add
COOLTOUCH ND: YAG LASER SYSTEM (K030453)New Star Lasers, Inc.2003-05-12+ Add
POWERLITE 600 EP SYSTEM (K030423)Preswede AB2003-05-09+ Add
DEPILASE YAG LASE PLUS LASER SYSTEM (K030506)Depilase Group , Ltd.2003-05-09+ Add
SMARTXIDE (K031224)Cynosure, Inc.2003-05-09+ Add
ARAMIS II DERMATOLOGICAL LASER (K023734)Quantel Medical2003-05-06+ Add
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 (K030959)Laser Peripherals, LLC2003-04-25+ Add
F1 DIODE LASER SYSTEM (K030235)Opus Medical, Inc.2003-04-23+ Add
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM (K030181)International Biophysics Corp.2003-04-17+ Add
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS (K030147)Lumenis, Ltd.2003-04-15+ Add
DIOLASE 980 D LASER SYSTEM (K023547)American Dental Technologies, Inc.2003-04-15+ Add
POLRIS LV (K030186)Syneron Medical, Ltd.2003-04-14+ Add
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM (K024371)Candela Corp.2003-03-31+ Add
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX (K023257)Prosurg, Inc.2003-03-28+ Add
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K024260)Candela Corp.2003-03-21+ Add
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES (K023954)Altus Medical, Inc.2003-03-18+ Add
CANDELA GENTLE YAG LASER SYSTEM (K022923)Candela Corp.2003-03-13+ Add
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K024335)Candela Corp.2003-03-12+ Add
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 (K024061)Peregrine Surgical , Ltd.2003-03-07+ Add
MEDLITE Q-SWITHCED LASER (K022709)Continuum Electro-Optics, Inc.2003-02-20+ Add
DUAL YELLOW LASER, MODEL D10B (K023899)Norseld Pty., Ltd.2003-02-20+ Add
ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 (K030338)Curelight, Ltd.2003-02-12+ Add
POLARIS DS (K024064)Syneron Medical, Ltd.2003-02-10+ Add
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA (K022807)Creative Technologies, Inc.2003-01-29+ Add
PALOMAR Q-YAG ND:YAG LASER SYSTEM (K023967)Palomar Medical Technologies, Inc.2003-01-27+ Add
TERABYTE 2000 HAIR REMOVER (K022341)Terabyte Co.2003-01-27+ Add
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 (K023624)Surgical Laser Technologies, Inc.2003-01-27+ Add
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG (K022951)Candela Corp.2003-01-27+ Add
CANDELA SMOOTHBEAM LASER SYSTEM (K022884)Candela Corp.2003-01-22+ Add
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR (K023464)Quantel Medical2003-01-13+ Add
LAD, MODEL LAD-01 (K021222)Norwood Abbey , Ltd.2003-01-08+ Add
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 (K024088)Biolitec, Inc.2003-01-02+ Add
PROFILE 1320 LASER SYSTEM (K022466)Sciton, Inc2002-12-31+ Add
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 (K023962)New Star Lasers, Inc.2002-12-24+ Add
CANDELA GENTLE YAG LASER SYSTEM (K023193)Candela Corp.2002-12-20+ Add
SPECTRAPULSE (K022607)Primary Technology, LLC2002-12-20+ Add
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