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 10 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101601 | AFFIRM DO DIODE LASER | Cynosure, Inc. | 2010-09-23 | Traditional | PDF ↗ |
| K092734 | E-LIGHT LINE | Espansione Marketing S.P.A | 2010-09-20 | Traditional | PDF ↗ |
| K101555 | CO2 LASER SYSTEM | Advanced Technology Laser Co., Ltd. | 2010-09-17 | Traditional | PDF ↗ |
| K100726 | CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM | Biolitec, Inc. | 2010-09-15 | Traditional | PDF ↗ |
| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | New Star Lasers, Inc. | 2010-09-13 | Traditional | PDF ↗ |
| K094049 | STLASE DIODE LASER | Dental Photonics, Inc. | 2010-09-10 | Traditional | PDF ↗ |
| K101152 | NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 | Focus Medical, LLC | 2010-08-18 | Traditional | PDF ↗ |
| K100098 | PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE | Jm System Co., Ltd. | 2010-08-13 | Traditional | PDF ↗ |
| K100143 | PILOT DIODE LASER, MODEL 002-00139 | CAO Group, Inc. | 2010-08-13 | Traditional | PDF ↗ |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | Biolase Technology, Inc. | 2010-08-11 | Traditional | PDF ↗ |
| K102050 | Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 | Advanced Technology Laser Co., Ltd. | 2010-07-29 | Traditional | PDF ↗ |
| K100558 | QUANTA DIODE LASER SYSTEM | Quanta System Spa | 2010-07-22 | Traditional | PDF ↗ |
| K100678 | SUPRA SCAN DELIVERY SYSTEM | Quantel Medical | 2010-07-21 | Traditional | PDF ↗ |
| K092860 | LASEMAR 800, 1000, 1500 | Eufoton S.R.L. | 2010-07-16 | Traditional | PDF ↗ |
| K101415 | THERACLEAR | Theravant Corporation | 2010-07-08 | Traditional | PDF ↗ |
| K100893 | CHEVEUX DIODE LASER SYSTEM | Sandstone Medical Technologies, LLC | 2010-06-16 | Traditional | PDF ↗ |
| K100746 | FIBER ONE | American Medical Systems | 2010-06-11 | Traditional | PDF ↗ |
| K100194 | OPTICAL INTEGRITY LASERGUARD FIBERS | Optical Integrity, Inc. | 2010-05-20 | Traditional | PDF ↗ |
| K093087 | BWF-5 MEDICAL LASER SERIES | Litecure, LLC | 2010-05-12 | Traditional | PDF ↗ |
| K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM | Lumenis | 2010-04-21 | Traditional | PDF ↗ |
| K100384 | FIBERLASE C02 LASER WAVEGUIDE | Lumenis, Ltd. | 2010-04-12 | Special | PDF ↗ |
| K100270 | ARTISAN AESTHETIC SYSTEM | Palomar Medical Technologies, Inc. | 2010-03-29 | Traditional | PDF ↗ |
| K093048 | D-STORM 810NM, D-STORM 980NM | Light Instruments | 2010-03-23 | Traditional | PDF ↗ |
| K100035 | MODEL VISULAS 532S LASER WITH THE VITE OPTION | Carl Zeiss Meditec, AG | 2010-03-17 | Special | PDF ↗ |
| K100474 | QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W | Quicklase Limited | 2010-03-16 | Traditional | PDF ↗ |
| K093852 | EZLASE 3 LASER SYSTEM | Biolase Technology, Inc. | 2010-03-12 | Traditional | PDF ↗ |
| K100228 | VERSAPULSE MODEL P20 LASER SYSTEM | Lumenis, Inc. | 2010-02-24 | Special | PDF ↗ |
| K093793 | LS-40 CO2 LASER SYSTEM MODEL LS-40 | Sandstone Medical Technologies, LLC | 2010-02-18 | Special | PDF ↗ |
| K100078 | MODIFIED STRAIGHT FIRE LASER FIBER | Boston Scientific Corp | 2010-02-12 | Traditional | PDF ↗ |
| K082230 | VECTRA PLUS LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 2010-02-03 | Traditional | PDF ↗ |
| K093162 | FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID | Fotona D.D. | 2010-01-22 | Traditional | PDF ↗ |
| K093502 | VARI-LASE ENDOVENOUS LASER CONSOLE | Vascular Solutions, Inc. | 2010-01-07 | Special | PDF ↗ |
| K090312 | TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC | Tria Beauty, Inc. | 2010-01-05 | Traditional | PDF ↗ |
| K082586 | LIGHTWAVE PROFESSIONAL DELUXE | Lightwave Technologies, LLC | 2010-01-04 | Traditional | PDF ↗ |
| K090820 | TRIA HAIR REMOVAL LASER SYSTEM | Spectragenics, Inc. | 2009-12-23 | Traditional | PDF ↗ |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | New Star Lasers, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K093691 | ACCUMAX | Boston Scientific Corp | 2009-12-11 | Traditional | PDF ↗ |
| K091746 | WATERLASE MD, MODEL 7100102 | Biolase Technology, Inc. | 2009-12-07 | Traditional | PDF ↗ |
| K092660 | SIROLASER ADVANCE | Sirona Dental Systems GmbH | 2009-12-03 | Special | PDF ↗ |
| K083123 | MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES | Medart A/S | 2009-11-24 | Traditional | PDF ↗ |
| K090195 | PALOMAR LUX1540 HANDPIECE | Palomar Medical Technologies, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP | Omniguide, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K092735 | GREENLIGHT XPS LASER SYSTEM | American Medical Systems, Inc. | 2009-11-09 | Traditional | PDF ↗ |
| K091625 | EPICARE-DUO LASER SYSTEM | Light Age, Inc. | 2009-11-03 | Traditional | PDF ↗ |
| K091115 | ECO2 LASER SYSTEM | Lutronic Corporation | 2009-10-30 | Special | PDF ↗ |
| K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM | Omniguide, Inc. | 2009-10-29 | Traditional | PDF ↗ |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | Biotex, Inc. | 2009-10-06 | Traditional | PDF ↗ |
| K083927 | WATERLASE MD | Biolase Technology, Inc. | 2009-10-01 | Traditional | PDF ↗ |
| K091800 | LIPOEZE LASER ASSISTED ASPIRATION CANNULA | Curve Medical | 2009-09-23 | Traditional | PDF ↗ |
| K091562 | DOCTOR SMILE A-810 AND B-980 LASERS | Lambda Scientific Spa | 2009-09-08 | Abbreviated | PDF ↗ |
| K091537 | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH | Cynosure, Inc. | 2009-09-03 | Traditional | PDF ↗ |
| K090762 | LEDA | Quantel Derma GmbH | 2009-08-28 | Traditional | PDF ↗ |
| K091320 | SPECTRA SP II, SPECTRA DENTA II | Lutronic Corporation | 2009-08-19 | Traditional | PDF ↗ |
| K090571 | ALMA LASERS ALEX755 MODULE | Alma Lasers , Ltd. | 2009-08-13 | Traditional | PDF ↗ |
| K091059 | FOXQ 980 LASER | A.R.C Laser GmbH | 2009-08-13 | Traditional | PDF ↗ |
| K091796 | SOFTLASE PRO, ORTHOLASE AND HYGIENELASE | Zap Lasers, LLC | 2009-07-31 | Traditional | PDF ↗ |
| K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | Optimedica Corporation | 2009-07-15 | Special | PDF ↗ |
| K091922 | WATERLASE C100, MODEL 7100104 | Biolase Technology, Inc. | 2009-07-14 | Special | PDF ↗ |
| K091909 | LITHO LASER SYSTEM | Quanta System Spa | 2009-07-09 | Traditional | PDF ↗ |
| K090126 | FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, | Fotona D.D. | 2009-06-29 | Traditional | PDF ↗ |
| K090164 | CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER | Biolitec, Inc. | 2009-06-26 | Traditional | PDF ↗ |
| K091551 | VARI-LASE PLATINUM BRIGHT TIP LASER FIBER | Vascular Solutions, Inc. | 2009-06-19 | Special | PDF ↗ |
| K090962 | CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM | Quanta System Spa | 2009-06-19 | Traditional | PDF ↗ |
| K083616 | PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS | Patholase, Inc. | 2009-06-12 | Traditional | PDF ↗ |
| K091323 | MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) | Intermedic Arfran, SA | 2009-06-04 | Special | PDF ↗ |
| K090776 | MEGAPULSE LASER SYSTEM AND FIBERS | Richard Wolf Medical Instruments Corp. | 2009-06-02 | Traditional | PDF ↗ |
| K083899 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Hoya Conbio, Inc. | 2009-06-01 | Traditional | PDF ↗ |
| K090094 | ZELTIQ SYSTEM | Zeltiq Aesthetics | 2009-05-20 | Special | PDF ↗ |
| K083253 | LOTUS II PULSED ER: YAG LASER SYSTEM | Laseroptek Co., Ltd. | 2009-05-15 | Traditional | PDF ↗ |
| K091169 | ELITE MPX LASER SYSTEM WITH CRYO C | Cynosure, Inc. | 2009-05-13 | Special | PDF ↗ |
| K083733 | LUME 2 SYSTEM, MODEL GA0005000 | Lumenis, Ltd. | 2009-05-04 | Traditional | PDF ↗ |
| K081509 | MONTERIS MEDICAL AUTOLITT LASER PROBE | Monteris Medical, | 2009-05-01 | Traditional | PDF ↗ |
| K083203 | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM | Laseroptek Co., Ltd. | 2009-04-28 | Traditional | PDF ↗ |
| K083889 | FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY | Fotona D.D. | 2009-04-23 | Traditional | PDF ↗ |
| K090297 | BLUESHINE GOLD SERIES | Blueshine Srl | 2009-04-14 | Traditional | PDF ↗ |
| K083848 | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM | Alma Lasers , Ltd. | 2009-04-14 | Traditional | PDF ↗ |
| K090618 | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C | Cynosure, Inc. | 2009-04-14 | Traditional | PDF ↗ |
| K083215 | INCISIVE FAMILY OF INPULSE ND:YAG LASERS | Incisive, LLC | 2009-04-08 | Traditional | PDF ↗ |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | New Star Lasers, Inc. | 2009-03-27 | Special | PDF ↗ |
| K082039 | SYNCHRO HP PLATFORM | El.En Electronic Engineering Spa | 2009-03-20 | Traditional | PDF ↗ |
| K081424 | AFFIRM CO2 AND AFFIRM CO2 HP | Cynosure, Inc. | 2009-03-19 | Traditional | PDF ↗ |
| K083478 | SMOOTHLIPO | Eleme Medical, Inc. | 2009-03-17 | Traditional | PDF ↗ |
| K090235 | ELITE MPX LASER SYSTEM WITH XPL HANDPIECE | Cynosure, Inc. | 2009-03-17 | Traditional | PDF ↗ |
| K083142 | PICASSO LASER SYSTEM | Amd Lasers, LLC | 2009-03-13 | Traditional | PDF ↗ |
| K090084 | ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE | Merit Medical Systems, Inc. | 2009-03-06 | Traditional | PDF ↗ |
| K090281 | ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES | Accutech Medical Technologies, Inc. | 2009-03-04 | Traditional | PDF ↗ |
| K083900 | ERBIUM FRACTIONAL HANDPIECE | Palomar Medical Products, Inc. | 2009-02-27 | Traditional | PDF ↗ |
| K081541 | DERMABLATE EFFECT | Asclepion Laser Technologies GmbH | 2009-02-23 | Traditional | PDF ↗ |
| K083165 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | 2009-02-13 | Traditional | PDF ↗ |
| K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | Dornier Medtech America, Inc. | 2009-02-12 | Traditional | PDF ↗ |
| K090181 | WATERLASE MD | Biolase Technology, Inc. | 2009-02-11 | Special | PDF ↗ |
| K082825 | ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM | Energist, Ltd. | 2009-02-06 | Traditional | PDF ↗ |
| K083034 | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F | Fotona D.D. | 2009-02-04 | Traditional | PDF ↗ |
| K082407 | MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM | Sandstone Medical Technologies, LLC | 2009-02-03 | Special | PDF ↗ |
| K083748 | IPULSE, MODEL: I150 | Cyden Limited | 2009-02-02 | Special | PDF ↗ |
| K083918 | ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 | Advanced Technology Laser Co., Ltd. | 2009-02-02 | Traditional | PDF ↗ |
| K083258 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | Dornier Medtech America, Inc. | 2009-01-30 | Traditional | PDF ↗ |
| K083915 | ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC | Advanced Technology Laser Co., Ltd. | 2009-01-29 | Traditional | PDF ↗ |
| K083795 | CYNOSURE SMARTLIPO MPX LASER | Cynosure, Inc. | 2009-01-21 | Special | PDF ↗ |
| K082409 | SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 | Endophotonix, Inc. | 2009-01-21 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.