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 12 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072779 | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 | Biolitec, Inc. | 2008-01-24 | Traditional | PDF ↗ |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Cook Urological, Inc. | 2008-01-23 | Traditional | PDF ↗ |
| K072906 | SILK'N | Home Skinovations , Ltd. | 2008-01-23 | Traditional | PDF ↗ |
| K071883 | IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 | Cyden Limited | 2008-01-23 | Special | PDF ↗ |
| K073464 | ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT | AngioDynamics, Inc. | 2008-01-23 | Special | PDF ↗ |
| K072332 | VARI-LASE WIRE FIBER | Vascular Solutions, Inc. | 2008-01-10 | Traditional | PDF ↗ |
| K072925 | CANDELA-INOLASE SERENITY PRO PSF SYSTEM | Inolase, Ltd. | 2008-01-10 | Traditional | PDF ↗ |
| K072331 | RADIANCY MISTRAL DEVICE | Radiancy (Israel) , Ltd. | 2008-01-07 | Traditional | PDF ↗ |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | New Star Lasers, Inc. | 2008-01-02 | Traditional | PDF ↗ |
| K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | Omniguide, Inc. | 2008-01-02 | Special | PDF ↗ |
| K073436 | SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM | Lutronic Corporation | 2007-12-28 | Traditional | PDF ↗ |
| K072159 | SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER | El.En Electronic Engineering Spa | 2007-12-27 | Traditional | PDF ↗ |
| K072484 | CYNOSURE YAG FAMILY LASER | Cynosure, Inc. | 2007-12-27 | Traditional | PDF ↗ |
| K072995 | TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER | Lumen Development and Manufacturing, Inc. | 2007-12-18 | Traditional | PDF ↗ |
| K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | Omniguide, Inc. | 2007-12-14 | Traditional | PDF ↗ |
| K073394 | SMARTLIPO LASER | Cynosure, Inc. | 2007-12-12 | Special | PDF ↗ |
| K073300 | MILESMAN PREMIUM | Milesman S.L. | 2007-12-04 | Traditional | PDF ↗ |
| K072344 | APL MEDICAL SYSTEM | Bios S.R.L. | 2007-12-03 | Traditional | PDF ↗ |
| K071815 | NOVEON, MODEL LS1100-01-0968 | Nomir Medical Technologies, Inc. | 2007-11-28 | Traditional | PDF ↗ |
| K071768 | ERBIUM FRACTIONAL HANDPIECE | Palomar Medical Products, Inc. | 2007-11-05 | Traditional | PDF ↗ |
| K072868 | ACCOLADE II LASER | Cynosure, Inc. | 2007-11-05 | Special | PDF ↗ |
| K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2007-11-02 | Traditional | PDF ↗ |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | Kavo America | 2007-10-26 | Traditional | PDF ↗ |
| K072767 | QUASAR BLUE LIGHT THERAPY SYSTEM | Silver Bay, LLC | 2007-10-15 | Traditional | PDF ↗ |
| K070870 | SKIN CARE LIGHT | Transverse Industries Co. | 2007-10-10 | Traditional | PDF ↗ |
| K071621 | RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2007-10-09 | Traditional | PDF ↗ |
| K070296 | VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM | Ace Vision Group | 2007-10-03 | Traditional | PDF ↗ |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | New Star Lasers, Inc. | 2007-10-03 | Special | PDF ↗ |
| K072514 | VISULAS TRION | Carl Zeiss Meditec, AG | 2007-09-21 | Traditional | PDF ↗ |
| K072034 | DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30 | Quanta System Spa | 2007-09-20 | Traditional | PDF ↗ |
| K072023 | ELLIPSE JUVIA, MODEL 9EJU7465 | Ellipse A/S | 2007-09-12 | Traditional | PDF ↗ |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | Biotex, Inc. | 2007-08-31 | Traditional | PDF ↗ |
| K072106 | 150W CERALAS D 980NM DIODE LASER | Biolitec, Inc. | 2007-08-30 | Special | PDF ↗ |
| K070185 | TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001 | Pharos Life Corporation | 2007-08-21 | Traditional | PDF ↗ |
| K071469 | INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM | Candela Corp. | 2007-08-15 | Traditional | PDF ↗ |
| K071943 | SERENITY PRO PSF SYSTEM | Inolase 2002, Ltd. | 2007-08-10 | Special | PDF ↗ |
| K071451 | TATTOOSTAR Y | Asclepion Laser Technologies GmbH | 2007-08-01 | Special | PDF ↗ |
| K071959 | ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT | AngioDynamics, Inc. | 2007-08-01 | Special | PDF ↗ |
| K063427 | LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM | Lynton Lasers Limited | 2007-07-25 | Traditional | PDF ↗ |
| K070392 | MOSAIC LASER SYSTEM | Lutronic Corporation | 2007-07-13 | Traditional | PDF ↗ |
| K070805 | ULTRAWAVE II EX 1320 | Quanta System Spa | 2007-07-11 | Traditional | PDF ↗ |
| K070298 | MODIFICATION TO PALOMAR LUXIR HANDPIECE | Palomar Medical Technologies, Inc. | 2007-07-03 | Special | PDF ↗ |
| K070924 | FLEXGUARD | Allmed Systems, Inc. | 2007-06-21 | Traditional | PDF ↗ |
| K071152 | PALOMAR ERBIUM HANDPIECE | Palomar Medical Products, Inc. | 2007-05-25 | Special | PDF ↗ |
| K070536 | MEDILAS D FAMILY LASERS | Dornier Medtech America, Inc. | 2007-05-21 | Traditional | PDF ↗ |
| K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | Reliant Technologies, Inc. | 2007-05-17 | Traditional | PDF ↗ |
| K071295 | 100W CERALAS D 980NM DIODE LASER | Biolitec, Inc. | 2007-05-16 | Traditional | PDF ↗ |
| K063104 | FOX MEDICAL DIODE LASER SYSTEM 810NM | Howard Instruments, Inc. | 2007-05-16 | Traditional | PDF ↗ |
| K070353 | KELSEY INTERSITITAL LASER THERAPY SYSTEM | Kelsey, Inc. | 2007-05-02 | Traditional | PDF ↗ |
| K070388 | PROFILE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2007-05-02 | Traditional | PDF ↗ |
| K070494 | EPI-C PLUS | Espansione Marketing S.P.A | 2007-05-01 | Traditional | PDF ↗ |
| K063808 | FRAXEL IV SR LASER SYSTEM | Reliant Technologies, Inc. | 2007-04-27 | Traditional | PDF ↗ |
| K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2007-04-27 | Traditional | PDF ↗ |
| K070466 | REVOLIX DUO LASER SYSTEM | Allmed Systems, Inc. | 2007-04-17 | Traditional | PDF ↗ |
| K062963 | PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 | Ra Medical Systems,Inc | 2007-04-03 | Traditional | PDF ↗ |
| K063867 | CUTERA ER:YSGG LASER HANDPIECE | Cutera, Inc. | 2007-03-27 | Traditional | PDF ↗ |
| K070138 | CUTERA ER:YAG LASER HANDPIECE | Cutera, Inc. | 2007-03-27 | Traditional | PDF ↗ |
| K070476 | REVOLIX 120 | Allmed Systems, Inc. | 2007-03-26 | Special | PDF ↗ |
| K062258 | GENESIS DIODE LASER | Ivoclar Vivadent, Inc. | 2007-03-21 | Traditional | PDF ↗ |
| K061489 | ATRILAZE MI SURGICAL ABLATION SYSTEM | Medical Cv, Inc. | 2007-03-16 | Abbreviated | PDF ↗ |
| K070216 | VARI-LASE BRIGHT TIP FIBER | Vascular Solutions, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K063384 | DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 | Hoya Conbio, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K070378 | ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT | AngioDynamics, Inc. | 2007-03-09 | Special | PDF ↗ |
| K063152 | CLAROS DENTAL LASER SYSTEM | Elexxion AG | 2007-03-07 | Abbreviated | PDF ↗ |
| K063001 | SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES | Lasering S.R.L. | 2007-03-07 | Traditional | PDF ↗ |
| K063698 | CO2 LASER SYSTEM, MODEL C-LAS | Clinicon Corp. | 2007-03-02 | Traditional | PDF ↗ |
| K062762 | DERMA YAG | El.En Electronic Engineering Spa | 2007-03-01 | Traditional | PDF ↗ |
| K061652 | PALOMAR LUX1540 HANDPIECE | Palomar Medical Products, Inc. | 2007-02-27 | Traditional | PDF ↗ |
| K063682 | INTRALASE FUSION LASER | Intra Lase Corp. | 2007-02-09 | Traditional | PDF ↗ |
| K063571 | PALOMAR LUX2940 HANDPIECE | Palomar Medical Technologies, Inc. | 2007-02-09 | Traditional | PDF ↗ |
| K063715 | JUNIPER COOLING DEVICE XTRA | Juniper Medical, Inc. | 2007-02-05 | Traditional | PDF ↗ |
| K063800 | CANDELA FLUORESCENT PULSED LIGHT SYSTEM | Candela Corp. | 2007-02-05 | Traditional | PDF ↗ |
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | Omniguide, Inc. | 2007-02-01 | Traditional | PDF ↗ |
| K061720 | COSMELIGHT | Penntack Enterprises, Inc. | 2007-01-31 | Traditional | PDF ↗ |
| K062303 | FRAXEL II SR LASER SYSTEM | Reliant Technologies, Inc. | 2007-01-31 | Traditional | PDF ↗ |
| K070063 | YAG MIR II LASER | Cynosure, Inc. | 2007-01-30 | Special | PDF ↗ |
| K061898 | EZLASE | Biolase Technology, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K063828 | DIOMED DELTA 25 | Diomed, Ltd. | 2007-01-25 | Special | PDF ↗ |
| K070071 | OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER | Omniguide, Inc. | 2007-01-25 | Traditional | PDF ↗ |
| K063834 | REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM | Hoya Conbio, Inc. | 2007-01-25 | Special | PDF ↗ |
| K063249 | BEAMAX | Medic Sharplight , Ltd. | 2007-01-17 | Traditional | PDF ↗ |
| K063396 | VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES | Lasering S.R.L. | 2007-01-17 | Traditional | PDF ↗ |
| K062363 | BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM | B&W Tek, Inc. | 2007-01-17 | Traditional | PDF ↗ |
| K063074 | CANDELA 3630 LASER SYSTEM | Candela Corp. | 2006-12-27 | Traditional | PDF ↗ |
| K062314 | HORUS LASER KERATOME | Carl Zeiss Meditec, AG | 2006-12-22 | Traditional | PDF ↗ |
| K063073 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Candela Corp. | 2006-12-20 | Traditional | PDF ↗ |
| K063072 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES | Candela Corp. | 2006-12-20 | Traditional | PDF ↗ |
| K061656 | LASER-D68 | Laser Pain Clinics LP | 2006-12-15 | Traditional | PDF ↗ |
| K061436 | PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2006-12-06 | Traditional | PDF ↗ |
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | Laserscope | 2006-12-01 | Traditional | PDF ↗ |
| K063112 | REVLITE Q-SWITCHED ND:YAG LASER | Hoya Conbio, Inc. | 2006-12-01 | Special | PDF ↗ |
| K062589 | SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM | Inolase 2002, Ltd. | 2006-11-30 | Traditional | PDF ↗ |
| K063060 | BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP | Blueshine Srl | 2006-11-29 | Traditional | PDF ↗ |
| K063141 | OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER | Omniguide, Inc. | 2006-11-29 | Traditional | PDF ↗ |
| K062822 | VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 | Vascular Solutions, Inc. | 2006-11-21 | Traditional | PDF ↗ |
| K062721 | GREENTON ECOLITE IPL SYSTEM | Greenton (London) , Ltd. | 2006-11-21 | Traditional | PDF ↗ |
| K062619 | DENLASER 800 PLUS | CAO Group, Inc. | 2006-11-14 | Traditional | PDF ↗ |
| K062871 | LUMACARE LC-122M NON-COHERENT LIGHT SOURCE | Lynton Lasers Limited | 2006-11-14 | Traditional | PDF ↗ |
| K062369 | IRIDEX OCULIGHT TX | Iridex Corp | 2006-11-08 | Traditional | PDF ↗ |
| K062321 | SMARTLIPO ND:YAG LASER | Cynosure, Inc. | 2006-10-31 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.