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 13 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060653 | THERMACLEAR | Dermacare, Inc. | 2006-10-24 | Traditional | PDF ↗ |
| K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | Optimedica Corporation | 2006-10-19 | Traditional | PDF ↗ |
| K062312 | AXIOM PULSED LIGHT SYSTEM | General Project S.R.L. | 2006-10-16 | Traditional | PDF ↗ |
| K061850 | MINI-YAG LASER | American Lasers, Inc. | 2006-09-29 | Traditional | PDF ↗ |
| K062071 | PROMETEY, MODEL G1-03 | Spectrum International | 2006-09-28 | Traditional | PDF ↗ |
| K060787 | TATTOOSTAR FAMILY | Asclepion Laser Technologies GmbH | 2006-09-27 | Special | PDF ↗ |
| K061966 | LITETOUCH DENTAL LASER SYSTEM | Light Instrument, Ltd. | 2006-09-27 | Traditional | PDF ↗ |
| K062210 | COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 | New Star Lasers, Inc. | 2006-09-25 | Traditional | PDF ↗ |
| K061618 | COOLTOUCH, MODEL CTEV | New Star Lasers, Inc. | 2006-09-25 | Traditional | PDF ↗ |
| K062423 | OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM | Omniguide, Inc. | 2006-09-21 | Special | PDF ↗ |
| K062048 | AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM | Aesthera Corporation | 2006-09-07 | Traditional | PDF ↗ |
| K053540 | INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE | Intermedic Arfran, SA | 2006-09-06 | Traditional | PDF ↗ |
| K062248 | AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM | North American Clinical Lasers, Ltd. | 2006-08-17 | Traditional | PDF ↗ |
| K060372 | INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 | Intra Lase Corp. | 2006-08-16 | Traditional | PDF ↗ |
| K061455 | DORNIER MEDILAS H 20 LASER | Dornier Medtech America, Inc. | 2006-08-01 | Traditional | PDF ↗ |
| K060966 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | Cooltouch, Inc. | 2006-07-31 | Traditional | PDF ↗ |
| K061470 | DEL SOL BLUE LIGHT THERAPY SYSTEM | Edge Systems Corporation | 2006-07-20 | Traditional | PDF ↗ |
| K061909 | HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 | Omniguide, Inc. | 2006-07-19 | Traditional | PDF ↗ |
| K061366 | DENLASER 800 PLUS | CAO Group, Inc. | 2006-07-10 | Traditional | PDF ↗ |
| K060448 | LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. | Lumenis, Ltd. | 2006-07-06 | Traditional | PDF ↗ |
| K052354 | OCULASE MD | Biolase Technology, Inc. | 2006-07-05 | Traditional | PDF ↗ |
| K061117 | NANOLITE SKIN CARE SYSTEM | Nanolite Technology, Inc. | 2006-06-20 | Abbreviated | PDF ↗ |
| K061178 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT | AngioDynamics, Inc. | 2006-06-12 | Traditional | PDF ↗ |
| K060905 | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 | Iridex Corp | 2006-05-31 | Traditional | PDF ↗ |
| K060407 | JUNIPER COOLING DEVICE | Juniper Medical Technology, Inc. | 2006-05-31 | Traditional | PDF ↗ |
| K060752 | ACMI DUR-HL LASER SYSTEMS | Acmi Corporation | 2006-05-25 | Traditional | PDF ↗ |
| K060977 | MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 | Hoya Conbio, Inc. | 2006-05-24 | Traditional | PDF ↗ |
| K051442 | PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT | Cynosure, Inc. | 2006-05-24 | Traditional | PDF ↗ |
| K060516 | ELLIPSE 12PL, MODEL 9ESL7228 | Danish Dermatologic Development A/S | 2006-05-15 | Abbreviated | PDF ↗ |
| K052371 | DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS | Hair International Systems USA, Inc. | 2006-05-04 | Traditional | PDF ↗ |
| K060567 | SPECTRAGENICS ATS-1 | Spectragenics, Inc. | 2006-04-28 | Traditional | PDF ↗ |
| K060680 | ATRILAZE SURGICAL ABLATION SYSTEM | Medical Cv, Inc. | 2006-04-11 | Special | PDF ↗ |
| K060114 | VECTRA LASER SYSTEM | Xintec Corporation, Dba, | 2006-04-07 | Traditional | PDF ↗ |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | Lumenis, Inc. | 2006-04-07 | Traditional | PDF ↗ |
| K060326 | LASERTX - DIODE LASER & DELIVERY SYSTEM | Prosurg, Inc. | 2006-04-05 | Traditional | PDF ↗ |
| K060310 | FRAXEL II SR LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K060301 | PALOMAR LUX1540 HANDPIECE | Palomar Medical Technologies, Inc. | 2006-03-23 | Traditional | PDF ↗ |
| K060411 | RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM | Radiancy (Israel) , Ltd. | 2006-03-22 | Traditional | PDF ↗ |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | Biotex, Inc. | 2006-03-21 | Traditional | PDF ↗ |
| K060457 | QUADROSTAR 532 | Asclepion Laser Technologies GmbH | 2006-03-20 | Special | PDF ↗ |
| K060459 | QUADROSTAR 980 | Asclepion Laser Technologies GmbH | 2006-03-20 | Special | PDF ↗ |
| K060455 | MULTISTAR | Asclepion Laser Technologies GmbH | 2006-03-20 | Special | PDF ↗ |
| K053047 | FRAXEL SR LASER SYSTEM | Reliant Technologies, Inc. | 2006-03-20 | Traditional | PDF ↗ |
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D | Ellex Medical Pty, Ltd. | 2006-03-16 | Traditional | PDF ↗ |
| K060216 | ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM | Energist, Ltd. | 2006-03-16 | Traditional | PDF ↗ |
| K060234 | MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM | Mccue Plc | 2006-03-15 | Traditional | PDF ↗ |
| K052310 | CRYOFLOW 700, CRYOFLOW 1000 | Uniphy Elektromedizin GmbH & Co. KG | 2006-03-15 | Abbreviated | PDF ↗ |
| K053616 | POLARIS WR, ST APPLICATOR | Syneron Medical, Ltd. | 2006-03-14 | Traditional | PDF ↗ |
| K053511 | DA VINCI FEMTOSECOND SURGICAL LASER | Sie Ltd Surgical Instrument Engineering | 2006-03-10 | Traditional | PDF ↗ |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | Lumenis, Inc. | 2006-03-09 | Special | PDF ↗ |
| K060069 | PALOMAR LUXIR FRACTIONAL HANDPIECE | Palomar Medical Technologies, Inc. | 2006-03-02 | Traditional | PDF ↗ |
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | Biotex, Inc. | 2006-03-01 | Traditional | PDF ↗ |
| K060033 | PROFILE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2006-02-28 | Traditional | PDF ↗ |
| K060395 | CRYO, MODEL V6.0 | Zimmer Elektromedizin GmbH | 2006-02-24 | Special | PDF ↗ |
| K053604 | WAVELIGHT IDAS | Wavelight Laser Technologie AG | 2006-02-22 | Traditional | PDF ↗ |
| K053139 | FOTONA QX ND:YAG/KTP LASER SYSTEM | Fotona D.D. | 2006-02-16 | Traditional | PDF ↗ |
| K053608 | CYNOSURE PHOTOGENICA V-STAR LASER | Cynosure, Inc. | 2006-02-13 | Traditional | PDF ↗ |
| K042114 | MDL SERIES DIODE LASERS, MODEL MDL-10/15 | Vision Lasertechnik, GmbH | 2006-02-03 | Traditional | PDF ↗ |
| K053421 | YAG MIR FAMILY LASER | Cynosure, Inc. | 2006-02-01 | Traditional | PDF ↗ |
| K052991 | RADIANCY FACIAL SKINCARE DEVICE | Radiancy (Israel) , Ltd. | 2006-02-01 | Traditional | PDF ↗ |
| K052442 | RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY | Radiancy (Israel) , Ltd. | 2006-01-26 | Traditional | PDF ↗ |
| K052680 | CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2006-01-23 | Traditional | PDF ↗ |
| K060050 | MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM | Biolitec, Inc. | 2006-01-23 | Traditional | PDF ↗ |
| K053161 | SIROLASER | Sirona Dental Systems GmbH | 2006-01-18 | Traditional | PDF ↗ |
| K053324 | CHROMOLITE SYSTEM | Chromogenex Plc | 2006-01-05 | Traditional | PDF ↗ |
| K051113 | QUANTA SYSTEM ETRNA GIOVINEZZA | Quanta System Spa | 2006-01-04 | Traditional | PDF ↗ |
| K052848 | SPECTRA HAIR REMOVAL LASER | Spectragenics, Inc. | 2005-12-27 | Traditional | PDF ↗ |
| K053457 | VAPORMAX II | Trimedyne, Inc. | 2005-12-21 | Traditional | PDF ↗ |
| K052604 | STARLITE 2006 | Laser Dental Innovations | 2005-12-16 | Traditional | PDF ↗ |
| K052688 | ELLIPSE FLEX PPT, MODEL 9ESF7255 | Danish Dermatologic Development A/S | 2005-12-12 | Abbreviated | PDF ↗ |
| K052874 | SOPRANO HAIR REMOVAL DIODE LASER | Msq (M2) , Ltd. | 2005-11-22 | Special | PDF ↗ |
| K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES | Lumenis, Inc. | 2005-11-15 | Traditional | PDF ↗ |
| K052806 | BURANE | Wavelight Laser Technologie AG | 2005-10-17 | Traditional | PDF ↗ |
| K052495 | ATRILAZE MALLEABLE ABLATION PROBE | Medical Cv, Inc. | 2005-10-11 | Special | PDF ↗ |
| K052336 | SPECTRAQUATTRO PULSED LIGHT SYSTEM | Amjet Distribution, LLC | 2005-10-11 | Traditional | PDF ↗ |
| K051508 | MED FLASH II INTENSE PULSED LIGHT SYSTEM. | General Project S.R.L. | 2005-10-05 | Traditional | PDF ↗ |
| K051259 | VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100 | Theralight, Inc. | 2005-09-20 | Traditional | PDF ↗ |
| K052324 | POLARIS LV, LVA APPLICATOR | Syneron Medical, Ltd. | 2005-09-14 | Special | PDF ↗ |
| K050382 | AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM | Cynosure, Inc. | 2005-09-14 | Traditional | PDF ↗ |
| K051876 | MULTIWAVE XR | Pacific Quantum Instruments, Inc. | 2005-09-09 | Abbreviated | PDF ↗ |
| K051671 | RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY | Radiancy (Israel) , Ltd. | 2005-09-02 | Traditional | PDF ↗ |
| K052129 | LUMENIS 1000 INTEGRATED SLIT LAMP | Lumenis, Inc. | 2005-08-30 | Traditional | PDF ↗ |
| K051996 | DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30 | Diomed, Ltd. | 2005-08-18 | Special | PDF ↗ |
| K050824 | 100W CERALAS D 980 LASER SYSTEM, MODEL D100 | Biolitec, Inc. | 2005-08-10 | Traditional | PDF ↗ |
| K051428 | VTRAC EXCIMER LAMP SYSTEM | Photo Medex, Inc. | 2005-08-09 | Traditional | PDF ↗ |
| K050216 | OMNILUX REVIVE AND OMNILUX PLUS | Photo Therapeutics Limited | 2005-08-09 | Traditional | PDF ↗ |
| K051434 | COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV | New Star Lasers, Inc. | 2005-08-09 | Traditional | PDF ↗ |
| K041893 | INTRALASE FS LASER | Intra Lase Corp. | 2005-07-29 | Traditional | PDF ↗ |
| K051287 | VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Vascular Solutions, Inc. | 2005-07-29 | Traditional | PDF ↗ |
| K043032 | DEALIGHT IPL | Europro, Inc. | 2005-07-19 | Traditional | PDF ↗ |
| K051359 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY | Candela Corp. | 2005-07-13 | Traditional | PDF ↗ |
| K051268 | RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT | Radiancy, Ltd. | 2005-07-06 | Traditional | PDF ↗ |
| K050841 | FRAXEL SR LASER SYSTEM | Reliant Technologies, Inc. | 2005-07-05 | Traditional | PDF ↗ |
| K051255 | LUMIPHASE-R | Opusmed, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K051399 | WAVELIGHT AURIGA | Wavelight Laser Technologie AG | 2005-06-30 | Traditional | PDF ↗ |
| K050779 | CYNERGY MULTIPLEX LASER | Cynosure, Inc. | 2005-06-27 | Traditional | PDF ↗ |
| K042630 | REVLIGHT SKIN CARE SYSTEM | Skincare Technology, Inc. | 2005-06-27 | Traditional | PDF ↗ |
| K050696 | MEDLITE C1 Q-SWITCHED ND:YAG LASER | Hoya Photonics, Inc. | 2005-06-17 | Traditional | PDF ↗ |
| K050673 | CANDELA FAMILY OF PULSE DYE LASER SYSTEMS | Candela Corp. | 2005-06-13 | Traditional | PDF ↗ |
| K050738 | FT FIBER OPTIC DELIVERY SYSTEMS | Fibertech GmbH | 2005-06-02 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.