FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 14 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K043377 | ZENO | Tyrell, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K051167 | REVOLIX AND REVOLIX JR | Allmed Systems, Inc. | 2005-06-01 | Traditional | PDF ↗ |
| K050453 | ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050 | Ivoclar Vivadent, Inc. | 2005-05-27 | Traditional | PDF ↗ |
| K050900 | MEDIOSTAR XT | Asclepion Laser Technologies GmbH | 2005-05-16 | Special | PDF ↗ |
| K050672 | ERCHONIA EVRL LASER | Erchonia Medical, Inc. | 2005-05-02 | Traditional | PDF ↗ |
| K050274 | DIODENT II DENTAL LASER SYSTEM | Hoya Photonics, Inc. | 2005-04-29 | Traditional | PDF ↗ |
| K050950 | MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS | Active Optical Systems, Ltd./Efraim Bidas | 2005-04-29 | Traditional | PDF ↗ |
| K041554 | AIP INTENSE PULSED LIGHT SYSTEM | Aesthera Corporation | 2005-04-27 | Traditional | PDF ↗ |
| K050165 | MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 | Cyden Limited | 2005-04-19 | Traditional | PDF ↗ |
| K050254 | SPECTRA-SP CO2 LASER SYSTEM | Max Engineering , Ltd. | 2005-04-15 | Traditional | PDF ↗ |
| K050562 | OCULIGHT GL/GLX | Iridex Corp | 2005-04-14 | Traditional | PDF ↗ |
| K050796 | AURORA DS, DS APPLICATOR | Syneron Medical, Ltd. | 2005-04-12 | Special | PDF ↗ |
| K050047 | CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY | Cutera, Inc. | 2005-03-31 | Traditional | PDF ↗ |
| K050679 | CUTERA SOLERA OPUS AESTHETIC PRODUCT | Cutera, Inc. | 2005-03-31 | Traditional | PDF ↗ |
| K043521 | BIOSYAG 50 MED | Bios S.R.L. | 2005-03-24 | Traditional | PDF ↗ |
| K050293 | FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS | Fotona D.D. | 2005-03-18 | Traditional | PDF ↗ |
| K050021 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Vascular Solutions, Inc. | 2005-03-18 | Traditional | PDF ↗ |
| K043329 | OMNILUX REVIVE AND BLUE | Photo Therapeutics Limited | 2005-03-18 | Traditional | PDF ↗ |
| K050108 | SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS | Innovaquartz | 2005-03-14 | Traditional | PDF ↗ |
| K050412 | VAPORMAX | Trimedyne, Inc. | 2005-03-14 | Traditional | PDF ↗ |
| K042319 | RELIANT LASER II SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2005-03-10 | Traditional | PDF ↗ |
| K050452 | AURORA SR AND SRA APPLICATOR | Syneron Medical, Ltd. | 2005-03-09 | Special | PDF ↗ |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | Topcon Medical Laser Systems, Inc. | 2005-03-03 | Traditional | PDF ↗ |
| K043575 | DERMILLUME, MODEL PRO1000 | Care Electronics, Inc. | 2005-02-24 | Traditional | PDF ↗ |
| K050317 | BURANE XL | Wavelight Laser Technologie AG | 2005-02-24 | Traditional | PDF ↗ |
| K043255 | ELLIPSE LIGHT SPT | Danish Dermatologic Development A/S | 2005-02-24 | Traditional | PDF ↗ |
| K050218 | WAVELIGHT SINON | Wavelight Laser Technologie AG | 2005-02-15 | Traditional | PDF ↗ |
| K043251 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B | Candela Corp. | 2005-02-09 | Traditional | PDF ↗ |
| K043046 | COOLTOUCH, MODEL CT3S | New Star Lasers, Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K050069 | CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT | Cutera, Inc. | 2005-01-31 | Traditional | PDF ↗ |
| K043173 | Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES | Lumenis, Ltd. | 2005-01-31 | Traditional | PDF ↗ |
| K040103 | SOUNDSKIN PHOTOTHERAPY SYSTEM | Bhc International, Ltd. | 2005-01-18 | Traditional | PDF ↗ |
| K041879 | PALOMAR LUX1064 HANDPIECE | Palomar Medical Technologies, Inc. | 2005-01-13 | Traditional | PDF ↗ |
| K041086 | PALOMAR STARLUX PULSED LIGHT SYSTEM | Palomar Medical Products, Inc. | 2005-01-13 | Traditional | PDF ↗ |
| K043429 | CYNERGY LASER | Cynosure, Inc. | 2005-01-12 | Special | PDF ↗ |
| K042000 | MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS | Msq (M2) , Ltd. | 2004-12-21 | Traditional | PDF ↗ |
| K043319 | CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES | Novalis Medical, LLC | 2004-12-17 | Traditional | PDF ↗ |
| K040270 | OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM | Lumenis, Ltd. | 2004-12-16 | Traditional | PDF ↗ |
| K031425 | GENTLEWAVES LED PHOTOMODULATION DEVICE | Light Bioscience, LLC | 2004-12-15 | Traditional | PDF ↗ |
| K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 | Nidek, Inc. | 2004-12-14 | Traditional | PDF ↗ |
| K041011 | ULTRALIGHT II ND:YAG LASER SYSTEM | Sandstone Medical Technologies, LLC | 2004-12-14 | Traditional | PDF ↗ |
| K043164 | PANALIGHT-BLU, MODEL 4175 | Dusa Pharmaceuticals, Inc. | 2004-12-10 | Traditional | PDF ↗ |
| K041957 | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS | Diomed, Inc. | 2004-12-01 | Traditional | PDF ↗ |
| K040744 | ATRILAZE SOFT TISSUE ABLATION SYSTEM | Medical Cv, Inc. | 2004-11-30 | Traditional | PDF ↗ |
| K042968 | MCL 30 DERMABLATE ER:YAG LASER SYSTEM | Asclepion Laser Technologies GmbH | 2004-11-24 | Special | PDF ↗ |
| K041242 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | 2004-11-22 | Traditional | PDF ↗ |
| K042918 | MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 | Endooptiks, Inc. | 2004-11-22 | Special | PDF ↗ |
| K041323 | PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA | New Star Lasers, Inc. | 2004-11-17 | Traditional | PDF ↗ |
| K043012 | OMNIPULSE MINI, MODEL 2120 | Trimedyne, Inc. | 2004-11-17 | Traditional | PDF ↗ |
| K041959 | POLARIS DS/COMET | Syneron Medical, Ltd. | 2004-11-08 | Traditional | PDF ↗ |
| K042211 | MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS | Surgical Laser Technologies, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K042496 | ADEPT ULTRALITE 532 LASER | Adept Medical Concepts | 2004-11-02 | Traditional | PDF ↗ |
| K041969 | AURORA DS | Syneron Medical, Ltd. | 2004-10-19 | Traditional | PDF ↗ |
| K041943 | XTRAC XL, MODEL AL8000 | Photo Medex, Inc. | 2004-10-14 | Traditional | PDF ↗ |
| K040563 | LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) | Sandstone Medical Technologies, LLC | 2004-10-08 | Traditional | PDF ↗ |
| K042439 | AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM | Diamond Age Systems, Inc. | 2004-10-07 | Traditional | PDF ↗ |
| K041994 | MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM | Curelight, Ltd. | 2004-10-06 | Traditional | PDF ↗ |
| K041767 | COOLCUBE COOLPEN | Bruce J. Sand M.D. | 2004-09-30 | Traditional | PDF ↗ |
| K042474 | ARION | Wavelight Laser Technologie AG | 2004-09-29 | Traditional | PDF ↗ |
| K041739 | EDWARDS E360 SURGICAL ABLATION DEVICE | Edwards Lifesciences, LLC | 2004-09-29 | Special | PDF ↗ |
| K040921 | COOLTOUCH, MODEL NS 160 | Cooltouch, Inc. | 2004-09-28 | Traditional | PDF ↗ |
| K032991 | LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX | Light Age, Inc. | 2004-09-14 | Traditional | PDF ↗ |
| K041930 | VARILITE LASER SYSTEM | Iridex Corporation | 2004-09-10 | Abbreviated | PDF ↗ |
| K042139 | VISULAS YAG III | Carl Zeiss Meditec, AG | 2004-09-09 | Special | PDF ↗ |
| K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | Trimedyne, Inc. | 2004-09-08 | Traditional | PDF ↗ |
| K041829 | FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS | Focus Medical, LLC | 2004-09-07 | Traditional | PDF ↗ |
| K041419 | LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM | Medical Energy, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K041262 | DURALITE-GL | Laser Scientific | 2004-08-13 | Traditional | PDF ↗ |
| K041721 | LVI AESTHETIC LASER | Hoya Photonics, Inc. | 2004-08-05 | Traditional | PDF ↗ |
| K041710 | VERSAWAVE DENTAL ER:YAG LASER SYSTEM | Hoya Conbio | 2004-08-03 | Traditional | PDF ↗ |
| K041103 | ACNELIFT | Inner Act, LLC | 2004-07-27 | Traditional | PDF ↗ |
| K030290 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | Millennium Dental Technologies, Inc. | 2004-07-26 | Traditional | PDF ↗ |
| K031140 | WATERLASE | Biolase Technology, Inc. | 2004-07-07 | Traditional | PDF ↗ |
| K041569 | CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002 | Curelight, Ltd. | 2004-06-30 | Special | PDF ↗ |
| K040617 | RELIANT LASER SYSTEM II | Reliant Technologies, Inc. | 2004-06-15 | Traditional | PDF ↗ |
| K040659 | MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM | Mccue Plc | 2004-06-01 | Traditional | PDF ↗ |
| K032397 | DUAL YELLOW LASER, MODEL DUAL YELLOW D10B | Norseld Pty., Ltd. | 2004-05-27 | Traditional | PDF ↗ |
| K041095 | PHOTOSILK PULSED LIGHT SYSTEM | Cynosure, Inc. | 2004-05-26 | Special | PDF ↗ |
| K040433 | SINON | Wavelight Laser Technologie AG | 2004-05-19 | Traditional | PDF ↗ |
| K040384 | MYDON C | Wavelight Laser Technologie AG | 2004-05-14 | Traditional | PDF ↗ |
| K040424 | LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 | Clarus Medical, LLC | 2004-05-11 | Traditional | PDF ↗ |
| K040294 | LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 | Photo Medex, Inc. | 2004-05-05 | Traditional | PDF ↗ |
| K030810 | COOLAN 300 | Coolanalgesia , Ltd. | 2004-05-05 | Traditional | PDF ↗ |
| K040289 | SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER | Cynosure, Inc. | 2004-04-30 | Traditional | PDF ↗ |
| K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004-04-23 | Traditional | PDF ↗ |
| K040131 | COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM | New Star Lasers, Inc. | 2004-04-20 | Traditional | PDF ↗ |
| K033183 | RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012 | Curelight, Ltd. | 2004-04-15 | Traditional | PDF ↗ |
| K040055 | POLYLASE LP | Ddc Technologies, Inc. | 2004-04-07 | Traditional | PDF ↗ |
| K032797 | DELIGHT DENTAL ER: YAG LASER SYSTEM | Hoya Photonics, Inc. | 2004-04-05 | Traditional | PDF ↗ |
| K040234 | LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM | Photo Medex, Inc. | 2004-04-02 | Traditional | PDF ↗ |
| K040081 | PALOMAR LUXV HANDPIECE | Palomar Medical Technologies, Inc. | 2004-04-01 | Traditional | PDF ↗ |
| K033072 | LUCENTLITE, MODEL IMD 010 | Industrial & Medical Design, Inc. | 2004-04-01 | Traditional | PDF ↗ |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | Laserscope | 2004-03-30 | Traditional | PDF ↗ |
| K040005 | PROFILE 2000/3000 LASER SYSTEM | Sciton, Inc | 2004-03-29 | Traditional | PDF ↗ |
| K040156 | IFL PROFESSIONAL SYSTEM, MODEL C100 | Cyden Limited | 2004-03-24 | Traditional | PDF ↗ |
| K032864 | CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 | Biolitec, Inc. | 2004-03-19 | Traditional | PDF ↗ |
| K032863 | CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 | Biolitec, Inc. | 2004-03-19 | Traditional | PDF ↗ |
| K033933 | POWERLITE 600 EX SYSTEM | Preswede AB | 2004-03-16 | Traditional | PDF ↗ |
| K033549 | STARLUX PULSED LIGHT SYSTEM | Palomar Medical Products, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K032459 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2004-03-09 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.