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 9 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123257 | EMVERA DIOLUX | Emvera Technologies, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K123385 | MEDILAS H LASER FIBERS | Dornier Medtech America, Inc. | 2012-12-14 | Special | PDF ↗ |
| K120932 | OPELASER PRO II AND THE OPELASER LITE II | The Yoshida Dental Mfg. Co., Ltd. | 2012-12-07 | Traditional | PDF ↗ |
| K123031 | BWF-5 MEDICAL LASER SERIES | Litecure, LLC | 2012-12-03 | Traditional | PDF ↗ |
| K123037 | LIGHTSCALPEL | Lightscalpel, LLC | 2012-11-29 | Traditional | PDF ↗ |
| K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM | Iridex Corp | 2012-11-28 | Traditional | PDF ↗ |
| K121346 | PICOSURE WORKSTATION | Cynosure, Inc. | 2012-11-27 | Traditional | PDF ↗ |
| K120460 | SMARTLUX | Medmix Co., Ltd. | 2012-10-01 | Traditional | PDF ↗ |
| K121286 | EPIC 10 | Biolase Technology, Inc. | 2012-09-28 | Special | PDF ↗ |
| K121580 | SURELASE CO2 LASER SYSTEM | Clinicon Corp. | 2012-09-25 | Traditional | PDF ↗ |
| K120235 | MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP | Aerolase Medical Lasers, LLC | 2012-09-17 | Traditional | PDF ↗ |
| K120737 | TRIA LASER HAIR REMOVAL SYSTEM | Tria Beauty, Inc. | 2012-09-13 | Traditional | PDF ↗ |
| K113472 | PRECISE SHP DIODE LASER | CAO Group, Inc. | 2012-08-30 | Traditional | PDF ↗ |
| K121938 | MEDILAS H RFID LASER FIBER | Dornier Medtech America, Inc. | 2012-08-01 | Special | PDF ↗ |
| K120926 | ENDOBEAM HOLMIUM LASER FIBERS | C.R. Bard, Inc. | 2012-07-27 | Traditional | PDF ↗ |
| K113489 | ORION | Asclepion Laser Technologies GmbH | 2012-07-27 | Traditional | PDF ↗ |
| K120377 | ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A | J. Morita USA, Inc. | 2012-07-25 | Traditional | PDF ↗ |
| K121162 | POLARIS Q-SWITCH RUBY SYSTEM | Sandstone Medical Technologies, LLC | 2012-07-18 | Traditional | PDF ↗ |
| K121471 | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS | Lightscalpel, LLC | 2012-07-10 | Traditional | PDF ↗ |
| K120810 | FIBEROPTIC LASER DELIVERY SYSTEM | Fiberoptic Fabrications, Inc. | 2012-06-28 | Traditional | PDF ↗ |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | Alcon Research, Ltd. | 2012-06-21 | Abbreviated | PDF ↗ |
| K120870 | GREENLIGHT MOXY FIBER OPTIC | American Medical Systems | 2012-06-15 | Special | PDF ↗ |
| K120573 | MEDART 620 | Medart A/S | 2012-06-13 | Special | PDF ↗ |
| K113868 | EPLUS SKIN TREATMENT SYSTEM | Syneron, Ltd. | 2012-06-11 | Traditional | PDF ↗ |
| K120622 | PALOMAR VECTUS LASER | Palomar Medical Technologies, Inc. | 2012-05-23 | Traditional | PDF ↗ |
| K121127 | SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS | Cynosure, Inc. | 2012-05-13 | Special | PDF ↗ |
| K112669 | TATTOOSTAR EFFECT Y | Asclepion Laser Technologies GmbH | 2012-05-11 | Traditional | PDF ↗ |
| K120437 | TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM | Biolitec Sia (Latvia) | 2012-04-26 | Traditional | PDF ↗ |
| K120231 | EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) | Biolitec Medical Devices, Inc. | 2012-04-24 | Traditional | PDF ↗ |
| K112141 | SMARTEPIL,DEPILASE YAG LASE PLUS | Castle Laser Systems, Limited | 2012-04-13 | Traditional | PDF ↗ |
| K112505 | ETHEREA | Regulatory Insight, Inc. | 2012-04-06 | Traditional | PDF ↗ |
| K113502 | ADVANTAGE LASER SYSTEM | Lutronic Corporation | 2012-04-05 | Traditional | PDF ↗ |
| K113115 | EPICARE YAG | Light Age, Inc. | 2012-04-03 | Traditional | PDF ↗ |
| K113688 | MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM | Biolitec Medical Devices, Inc. | 2012-03-13 | Traditional | PDF ↗ |
| K113151 | IFS LASER SYSTEM | Abbott Medical Optics, Inc. | 2012-03-08 | Traditional | PDF ↗ |
| K113588 | SPECTRA LASER SYSTEM | Lutronic Corporation | 2012-02-22 | Traditional | PDF ↗ |
| K111689 | STLASE | Dental Photonics, Inc. | 2012-02-16 | Traditional | PDF ↗ |
| K113390 | LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) | Meridian AG | 2012-02-14 | Traditional | PDF ↗ |
| K112600 | ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT | AngioDynamics, Inc. | 2012-01-30 | Traditional | PDF ↗ |
| K113858 | MEGABEAM ENDO-ENT PROBE | Biolitec Medical Devices, Inc. | 2012-01-24 | Traditional | PDF ↗ |
| K113709 | MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE | Biolitec Medical Devices, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K113792 | MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE | Biolitec Medical Devices, Inc. | 2012-01-19 | Traditional | PDF ↗ |
| K112013 | EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER | Biolitec, Inc. | 2012-01-13 | Traditional | PDF ↗ |
| K113140 | VARI-LASE WIREFIBER LASER FIBER | Vascular Solutions, Inc. | 2011-12-22 | Special | PDF ↗ |
| K111303 | DERMATOLOGICAL TREATMENT DEVICE FAMILY | Sharplight Technologies, Ltd. | 2011-12-21 | Traditional | PDF ↗ |
| K112987 | TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM | Biolitec Medical Devices, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 | Dornier Medtech America, Inc. | 2011-12-07 | Traditional | PDF ↗ |
| K113212 | DENTAL LASER THERAPY SYSTEM | China Daheng Group, Inc. | 2011-11-16 | Traditional | PDF ↗ |
| K112299 | ENDOVASCULAR LASER VEIN SYSTEM KIT | Biolitec Medical Devices, Inc. | 2011-11-03 | Traditional | PDF ↗ |
| K112166 | ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE | W and R Investments Dba Laser Engineering | 2011-10-21 | Traditional | PDF ↗ |
| K112715 | CANDELA GENTLEMAX FAMILY OF LASERS | Candela Corp. | 2011-10-05 | Traditional | PDF ↗ |
| K112442 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | Biolitec Medical Devices, Inc. | 2011-09-30 | Traditional | PDF ↗ |
| K111475 | AURIGA XL | Starmedtec GmbH | 2011-09-28 | Traditional | PDF ↗ |
| K112253 | CERALAS 147NM DIODE LASER SYSTEM | Biolitec, Inc. | 2011-09-20 | Traditional | PDF ↗ |
| K102359 | PICASSO/ PICASSO LITE/ PICASSO PERIO | Amd Lasers, LLC | 2011-09-16 | Abbreviated | PDF ↗ |
| K111360 | SHEAUMANN PL-980 | Sheaumann Lasers | 2011-09-14 | Traditional | PDF ↗ |
| K111359 | SHEAUMANN PL-1064 | Sheaumann Lasers | 2011-09-13 | Traditional | PDF ↗ |
| K112031 | ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION | Alma Lasers, Inc. | 2011-09-13 | Special | PDF ↗ |
| K112324 | CERALAS 980NM DIODE LASER FAMILY | Biolitec Medical Devices, Inc. | 2011-09-06 | Traditional | PDF ↗ |
| K111592 | YOULASER CO2 LASER SYSTEM | Quanta System Spa | 2011-08-25 | Traditional | PDF ↗ |
| K111213 | VISION ONE LASER SYSTEM | Lumenis, Inc. | 2011-07-25 | Special | PDF ↗ |
| K111144 | CANDELA GENTLELASE FAMILY OF LASERS | Candela Corp. | 2011-07-18 | Traditional | PDF ↗ |
| K111851 | MEDIOSTAR NEXT | Asclepion Laser Technologies GmbH | 2011-07-08 | Special | PDF ↗ |
| K101306 | SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A | Fotona D.D. | 2011-07-01 | Traditional | PDF ↗ |
| K110897 | CORTEX CO2 / ER:YAG LASER SYSTEM | Sandstone Medical Technologies, LLC | 2011-07-01 | Traditional | PDF ↗ |
| K110243 | MEDART DIODE LASER SYSTEM & ACCESSORIES | Medart A/S | 2011-06-28 | Traditional | PDF ↗ |
| K110907 | PALOMAR ICON (TM) AESTHETIC SYSTEM | Palomar Medical Technologies, Inc. | 2011-06-22 | Traditional | PDF ↗ |
| K102954 | CUTERA QSWITCH LASER SYSTEM | Cutera, Inc. | 2011-06-22 | Traditional | PDF ↗ |
| K110225 | ANGIODYNAMICS, INC. VENACURE 1470 LASER | AngioDynamics, Inc. | 2011-05-13 | Traditional | PDF ↗ |
| K103455 | SPECTRA LASER SYSTEM | Lutronic Corporation | 2011-04-28 | Special | PDF ↗ |
| K110502 | TRIPLEX ER. YAG / ND: YAG SYSTEM | Sandstone Medical Technologies, LLC | 2011-04-27 | Traditional | PDF ↗ |
| K110434 | TRIXEL CO2 LASER | BEIJING SYNTECH LASER CO., LTD. | 2011-04-19 | Traditional | PDF ↗ |
| K110304 | APEX ER. YAG / IPL SYSTEM | Sandstone Medical Technologies, LLC | 2011-04-08 | Traditional | PDF ↗ |
| K103654 | VELA XL | Starmedtec GmbH | 2011-04-06 | Traditional | PDF ↗ |
| K110685 | FLEXIVA TRACTIP | Boston Scientific Corp | 2011-03-29 | Special | PDF ↗ |
| K110686 | ACCUTRAC | Boston Scientific Corp | 2011-03-28 | Special | PDF ↗ |
| K101916 | JOULE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2011-03-18 | Traditional | PDF ↗ |
| K110080 | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM | Biolitec, Inc. | 2011-02-24 | Traditional | PDF ↗ |
| K103753 | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER | Sirona Dental Systems GmbH | 2011-02-15 | Traditional | PDF ↗ |
| K110079 | SPPHINE PLUS STM 3W DIODE LASER | Den-Mat Holdings, LLC | 2011-02-10 | Traditional | PDF ↗ |
| K103288 | DEKA SYNCHRO FT | El.En Electronic Engineering Spa | 2011-01-31 | Traditional | PDF ↗ |
| K103539 | QUANTA SYSTEM DUOLITE | Quanta System Spa | 2011-01-20 | Traditional | PDF ↗ |
| K103501 | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES | Alma Lasers, Inc. | 2011-01-14 | Special | PDF ↗ |
| K101904 | SMARTXIDE 50 HS/MS | El.En Electronic Engineering Spa | 2011-01-12 | Traditional | PDF ↗ |
| K103667 | SAPPHIRE ST PORTABLE DIODE LASER | Den-Mat Holdings, LLC | 2010-12-29 | Traditional | PDF ↗ |
| K102755 | CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER | Biolitec, Inc. | 2010-12-16 | Traditional | PDF ↗ |
| K102796 | ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT | AngioDynamics, Inc. | 2010-12-15 | Traditional | PDF ↗ |
| K102749 | QUANTA CYBER TM 150W | Quanta System Spa | 2010-12-10 | Traditional | PDF ↗ |
| K102639 | SL3 | Discus Dental, LLC | 2010-12-01 | Special | PDF ↗ |
| K100199 | ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT | AngioDynamics, Inc. | 2010-11-26 | Traditional | PDF ↗ |
| K101817 | LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N | Fotona D.D. | 2010-11-22 | Traditional | PDF ↗ |
| K103118 | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR | Hoya Photonics, Inc. | 2010-11-19 | Special | PDF ↗ |
| K102669 | DIODE LASER THERAPY SYSTEM | China Daheng Group, Inc. | 2010-11-17 | Traditional | PDF ↗ |
| K101321 | EMATRIX CO2 | Syneron Medical, Ltd. | 2010-11-09 | Traditional | PDF ↗ |
| K101712 | ENDOVASCULAR LAER VEIN SYSTEM KIT | Biolitec, Inc. | 2010-10-27 | Traditional | PDF ↗ |
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | Alcon Research, Ltd. | 2010-10-21 | Traditional | PDF ↗ |
| K093545 | PINPOINTE FOOTLASER MODEL 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010-10-15 | Traditional | PDF ↗ |
| K102036 | DOCTOR SURGERY DIODE LASERS FAMILY | Lambda S.P.A. | 2010-09-28 | Abbreviated | PDF ↗ |
| K102716 | MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS | Alma Lasers, Inc. | 2010-09-28 | Special | PDF ↗ |
| K101601 | AFFIRM DO DIODE LASER | Cynosure, Inc. | 2010-09-23 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.