Atlas FDA

GEX

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.

RecordFirmDateBuilder
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K050021)Vascular Solutions, Inc.2005-03-18+ Add
OMNILUX REVIVE AND BLUE (K043329)Photo Therapeutics Limited2005-03-18+ Add
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS (K050293)Fotona D.D.2005-03-18+ Add
VAPORMAX (K050412)Trimedyne, Inc.2005-03-14+ Add
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS (K050108)Innovaquartz2005-03-14+ Add
RELIANT LASER II SYSTEM AND ACCESSORIES (K042319)Reliant Technologies, Inc.2005-03-10+ Add
AURORA SR AND SRA APPLICATOR (K050452)Syneron Medical, Ltd.2005-03-09+ Add
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 (K043486)Topcon Medical Laser Systems, Inc.2005-03-03+ Add
ELLIPSE LIGHT SPT (K043255)Danish Dermatologic Development A/S2005-02-24+ Add
BURANE XL (K050317)Wavelight Laser Technologie AG2005-02-24+ Add
DERMILLUME, MODEL PRO1000 (K043575)Care Electronics, Inc.2005-02-24+ Add
WAVELIGHT SINON (K050218)Wavelight Laser Technologie AG2005-02-15+ Add
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B (K043251)Candela Corp.2005-02-09+ Add
COOLTOUCH, MODEL CT3S (K043046)New Star Lasers, Inc.2005-02-01+ Add
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT (K050069)Cutera, Inc.2005-01-31+ Add
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES (K043173)Lumenis, Ltd.2005-01-31+ Add
SOUNDSKIN PHOTOTHERAPY SYSTEM (K040103)Bhc International, Ltd.2005-01-18+ Add
PALOMAR STARLUX PULSED LIGHT SYSTEM (K041086)Palomar Medical Products, Inc.2005-01-13+ Add
PALOMAR LUX1064 HANDPIECE (K041879)Palomar Medical Technologies, Inc.2005-01-13+ Add
CYNERGY LASER (K043429)Cynosure, Inc.2005-01-12+ Add
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS (K042000)Msq (M2) , Ltd.2004-12-21+ Add
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES (K043319)Novalis Medical, LLC2004-12-17+ Add
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM (K040270)Lumenis, Ltd.2004-12-16+ Add
GENTLEWAVES LED PHOTOMODULATION DEVICE (K031425)Light Bioscience, LLC2004-12-15+ Add
ULTRALIGHT II ND:YAG LASER SYSTEM (K041011)Sandstone Medical Technologies, LLC2004-12-14+ Add
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 (K042785)Nidek, Inc.2004-12-14+ Add
PANALIGHT-BLU, MODEL 4175 (K043164)Dusa Pharmaceuticals, Inc.2004-12-10+ Add
EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS (K041957)Diomed, Inc.2004-12-01+ Add
ATRILAZE SOFT TISSUE ABLATION SYSTEM (K040744)Medical Cv, Inc.2004-11-30+ Add
MCL 30 DERMABLATE ER:YAG LASER SYSTEM (K042968)Asclepion Laser Technologies GmbH2004-11-24+ Add
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 (K042918)Endooptiks, Inc.2004-11-22+ Add
CANDELA SMOOTHBEAM LASER SYSTEM (K041242)Candela Corp.2004-11-22+ Add
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA (K041323)New Star Lasers, Inc.2004-11-17+ Add
OMNIPULSE MINI, MODEL 2120 (K043012)Trimedyne, Inc.2004-11-17+ Add
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS (K042211)Surgical Laser Technologies, Inc.2004-11-08+ Add
POLARIS DS/COMET (K041959)Syneron Medical, Ltd.2004-11-08+ Add
ADEPT ULTRALITE 532 LASER (K042496)Adept Medical Concepts2004-11-02+ Add
AURORA DS (K041969)Syneron Medical, Ltd.2004-10-19+ Add
XTRAC XL, MODEL AL8000 (K041943)Photo Medex, Inc.2004-10-14+ Add
LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) (K040563)Sandstone Medical Technologies, LLC2004-10-08+ Add
AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM (K042439)Diamond Age Systems, Inc.2004-10-07+ Add
MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM (K041994)Curelight, Ltd.2004-10-06+ Add
COOLCUBE COOLPEN (K041767)Bruce J. Sand M.D.2004-09-30+ Add
ARION (K042474)Wavelight Laser Technologie AG2004-09-29+ Add
EDWARDS E360 SURGICAL ABLATION DEVICE (K041739)Edwards Lifesciences, LLC2004-09-29+ Add
COOLTOUCH, MODEL NS 160 (K040921)Cooltouch, Inc.2004-09-28+ Add
LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX (K032991)Light Age, Inc.2004-09-14+ Add
VARILITE LASER SYSTEM (K041930)Iridex Corporation2004-09-10+ Add
VISULAS YAG III (K042139)Carl Zeiss Meditec, AG2004-09-09+ Add
TRIMEDYNE HOLMIUM LASER SYSTEMS (K041660)Trimedyne, Inc.2004-09-08+ Add
FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS (K041829)Focus Medical, LLC2004-09-07+ Add
LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM (K041419)Medical Energy, Inc.2004-08-26+ Add
DURALITE-GL (K041262)Laser Scientific2004-08-13+ Add
LVI AESTHETIC LASER (K041721)Hoya Photonics, Inc.2004-08-05+ Add
VERSAWAVE DENTAL ER:YAG LASER SYSTEM (K041710)Hoya Conbio2004-08-03+ Add
ACNELIFT (K041103)Inner Act, LLC2004-07-27+ Add
PERIOLASE ND:YAG DENTAL LASER SYSTEM (K030290)Millennium Dental Technologies, Inc.2004-07-26+ Add
WATERLASE (K031140)Biolase Technology, Inc.2004-07-07+ Add
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 (K041569)Curelight, Ltd.2004-06-30+ Add
RELIANT LASER SYSTEM II (K040617)Reliant Technologies, Inc.2004-06-15+ Add
MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM (K040659)Mccue Plc2004-06-01+ Add
DUAL YELLOW LASER, MODEL DUAL YELLOW D10B (K032397)Norseld Pty., Ltd.2004-05-27+ Add
PHOTOSILK PULSED LIGHT SYSTEM (K041095)Cynosure, Inc.2004-05-26+ Add
SINON (K040433)Wavelight Laser Technologie AG2004-05-19+ Add
MYDON C (K040384)Wavelight Laser Technologie AG2004-05-14+ Add
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 (K040424)Clarus Medical, LLC2004-05-11+ Add
LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 (K040294)Photo Medex, Inc.2004-05-05+ Add
COOLAN 300 (K030810)Coolanalgesia , Ltd.2004-05-05+ Add
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER (K040289)Cynosure, Inc.2004-04-30+ Add
CRYO 5 (K040727)Zimmer Elektromedizin GmbH2004-04-23+ Add
COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM (K040131)New Star Lasers, Inc.2004-04-20+ Add
RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 (K033183)Curelight, Ltd.2004-04-15+ Add
POLYLASE LP (K040055)Ddc Technologies, Inc.2004-04-07+ Add
DELIGHT DENTAL ER: YAG LASER SYSTEM (K032797)Hoya Photonics, Inc.2004-04-05+ Add
LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM (K040234)Photo Medex, Inc.2004-04-02+ Add
PALOMAR LUXV HANDPIECE (K040081)Palomar Medical Technologies, Inc.2004-04-01+ Add
LUCENTLITE, MODEL IMD 010 (K033072)Industrial & Medical Design, Inc.2004-04-01+ Add
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES (K034011)Laserscope2004-03-30+ Add
PROFILE 2000/3000 LASER SYSTEM (K040005)Sciton, Inc2004-03-29+ Add
IFL PROFESSIONAL SYSTEM, MODEL C100 (K040156)Cyden Limited2004-03-24+ Add
CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 (K032864)Biolitec, Inc.2004-03-19+ Add
CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 (K032863)Biolitec, Inc.2004-03-19+ Add
POWERLITE 600 EX SYSTEM (K033933)Preswede AB2004-03-16+ Add
STARLUX PULSED LIGHT SYSTEM (K033549)Palomar Medical Products, Inc.2004-03-10+ Add
PROFILE 1320 LASER SYSTEM (K032459)Sciton, Inc2004-03-09+ Add
THE FRIENDLYLIGHT ND: YAG LASERS (K033251)Innotech USA, Inc.2004-03-02+ Add
LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 (K033259)Light Age, Inc.2004-02-25+ Add
LAD (EPITURE EASYTOUCH), MODEL LAD-08 (K033962)Norwood Abbey , Ltd.2004-02-20+ Add
FEMTEC LASER MICROKERATOME (K033354)20/10 Perfect Vision Optische Gerate GmbH2004-02-18+ Add
APOGEE ELITE (K034030)Cynosure, Inc.2004-02-09+ Add
WATERLASE (K030523)Biolase Technology, Inc.2004-01-30+ Add
AC APPLICATOR, AURORA AC (K032514)Syneron Medical, Ltd.2004-01-27+ Add
FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) (K032667)Focus Medical, LLC2004-01-23+ Add
TRISTAR AESTHETIC WORKSTATION LASER (K033176)Cynosure, Inc.2004-01-21+ Add
SPHINX LASER SYSTEMS (K033437)Allmed Systems, Inc.2004-01-20+ Add
CANDELA VBEAM PULSE DYE LASER SYSTEM (K033461)Candela Corp.2004-01-16+ Add
CANDELA CBEAM PULSE DYE LASER SYSTEM (K033331)Candela Corp.2004-01-16+ Add
REVOLIX LASER SYSTEMS (K033423)Allmed Systems, Inc.2004-01-15+ Add
CLINICAL LASETTE P-200 (K033799)Cell Robotics, Inc.2003-12-22+ Add
YA-MAN LASER 21 (K032944)Ya-Man, Ltd.2003-12-19+ Add
← Previous Next →

Track GEX automatically

Every clearance here is in the API, with alerts when new ones post.