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 8 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131987 | MULTIPULSE HOPLUS | Asclepion Laser Technologies GmbH | 2014-10-15 | Traditional | PDF ↗ |
| K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER | Oberon GmbH Fiber Technologies | 2014-10-15 | Traditional | PDF ↗ |
| K142614 | AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits | AngioDynamics, Inc. | 2014-10-10 | Special | PDF ↗ |
| K140120 | EPIC 10 | Biolase, Inc. | 2014-10-10 | Traditional | PDF ↗ |
| K140249 | LONG PULSE ND: YAG LASER SYSTEM | Advanced Technology Laser Co., Ltd. | 2014-10-08 | Traditional | PDF ↗ |
| K141973 | DIODE LASER HAIR REMOVAL SYSTEM | Beijing Anchorfree Technology Co., Ltd. | 2014-10-06 | Traditional | PDF ↗ |
| K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | Omniguide, Inc. | 2014-09-25 | Traditional | PDF ↗ |
| K142376 | Palomar Icon Aesthetic System | Cynosure, Inc. | 2014-09-24 | Special | PDF ↗ |
| K140837 | LUCID LY | Bio-Med USA, Inc. | 2014-09-24 | Traditional | PDF ↗ |
| K140719 | PICOSURE WORKSTATION | Cynosure, Inc. | 2014-09-22 | Traditional | PDF ↗ |
| K142223 | Pilot Pro Diode Laser | CAO Group, Inc. | 2014-09-12 | Special | PDF ↗ |
| K142225 | Pilot Elite Diode Laser | CAO Group, Inc. | 2014-09-12 | Special | PDF ↗ |
| K142226 | Pilot Ultra Diode Laser | CAO Group, Inc. | 2014-09-12 | Special | PDF ↗ |
| K141425 | ELITE + LASER SYSTEM | Cynosure, Inc. | 2014-09-11 | Special | PDF ↗ |
| K133895 | DEKA SMARTXIDE LASER SYSTEM | El.En S.P.A. | 2014-09-05 | Traditional | PDF ↗ |
| K140964 | CALCULASE II | KARL STORZ Endoscopy-America, Inc. | 2014-09-04 | Traditional | PDF ↗ |
| K140009 | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM | Alma Lasers , Ltd. | 2014-08-29 | Traditional | PDF ↗ |
| K140458 | DIOTECH LASER FIBER | Diotech CO | 2014-08-26 | Traditional | PDF ↗ |
| K140366 | ENDLESSFIBER REUSABLE SURGICAL LASER FIBER | Hogue Surgical, LLC | 2014-08-15 | Traditional | PDF ↗ |
| K133945 | CUTERA PICOSECOND LASER SYSTEM | Cutera, Inc. | 2014-08-11 | Traditional | PDF ↗ |
| K141983 | NEUROBLATE SYSTEM | Monteris Medical Corp. | 2014-08-11 | Special | PDF ↗ |
| K141101 | LITHO | Quanta System Spa | 2014-08-08 | Special | PDF ↗ |
| K141403 | LITHO DK30 | Quanta System Spa | 2014-08-07 | Special | PDF ↗ |
| K141838 | SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) | Regulatory Technology Services, LLC | 2014-07-25 | Traditional | PDF ↗ |
| K133364 | PICOSURE WORKSTATION | Cynosure, Inc. | 2014-07-22 | Traditional | PDF ↗ |
| K140005 | ALMA DIODE TABLETOP LASER | Alma Lasers , Ltd. | 2014-07-18 | Traditional | PDF ↗ |
| K131757 | TATTOOSTAR EFFECT COMBO | Asclepion Laser Technologies GmbH | 2014-07-17 | Traditional | PDF ↗ |
| K141063 | LINSCAN 808, LINSCAN 980 | Gme (German Medical Engineering) GmbH | 2014-07-15 | Traditional | PDF ↗ |
| K132806 | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE | Fotona D.D. | 2014-07-11 | Traditional | PDF ↗ |
| K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | American Medical Systems | 2014-06-20 | Traditional | PDF ↗ |
| K133297 | QUADROSTARPROGREEN, QUADROSTARPROYELLOW | Asclepion Laser Technologies GmbH | 2014-06-10 | Traditional | PDF ↗ |
| K133774 | ATOVEN | Bio-Med USA, Inc. | 2014-06-06 | Traditional | PDF ↗ |
| K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM | Candela Corp. | 2014-05-09 | Traditional | PDF ↗ |
| K131838 | DIODE LASER FOR HIAR REMOVAL | Beijing Honkon Technologies Co., Ltd. | 2014-04-24 | Traditional | PDF ↗ |
| K133915 | GALAXY CO2 LASER SYSTEM | Beijing Toplaser Technology Co., Ltd. | 2014-04-18 | Traditional | PDF ↗ |
| K133006 | NEOV DIODE LASER FAMILY | G.N.S Neolaser , Ltd. | 2014-04-17 | Traditional | PDF ↗ |
| K132976 | ADVATX | Advalight Aps | 2014-04-17 | Traditional | PDF ↗ |
| K140503 | FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER | Boston Scientific | 2014-04-15 | Traditional | PDF ↗ |
| K133837 | VIORA V-TOTAL | Viora , Ltd. | 2014-04-09 | Traditional | PDF ↗ |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 2014-03-21 | Traditional | PDF ↗ |
| K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 | Lumenis, Ltd. | 2014-03-20 | Traditional | PDF ↗ |
| K132975 | SPHINX JR | Allmed Systems, Inc. | 2014-03-18 | Traditional | PDF ↗ |
| K140388 | LUMENIS PULSE 120H | Lumenis, Ltd. | 2014-03-14 | Special | PDF ↗ |
| K122358 | NOVEON | Hogan Lovells US LLP | 2014-03-11 | Traditional | PDF ↗ |
| K133254 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Cynosure, Inc. | 2014-03-05 | Traditional | PDF ↗ |
| K133158 | ND: YAG LASER SYSTEM | Beijing Toplaser Technology Co., Ltd. | 2014-02-28 | Traditional | PDF ↗ |
| K132989 | SPEED 808 DIODE LASER SYSTEM | Beijing Toplaser Technology Co., Ltd. | 2014-01-23 | Traditional | PDF ↗ |
| K131837 | CO2 FRACTIONAL LASER | Beijing Honkon Technologies Co., Ltd. | 2014-01-22 | Traditional | PDF ↗ |
| K132286 | HYPERION LONG PULSED ND: YAG LASER | Scarlet Rf, Inc. | 2014-01-22 | Traditional | PDF ↗ |
| K131857 | Q-SWITCHED ND:YAG LASER | Beijing Honkon Technologies Co., Ltd. | 2014-01-16 | Traditional | PDF ↗ |
| K130681 | ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER | Biolitec Sia | 2014-01-08 | Traditional | PDF ↗ |
| K132661 | LIGHTSCALPEL | Lightscalpel, LLC | 2014-01-02 | Traditional | PDF ↗ |
| K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS | Candela Corp. | 2013-12-26 | Special | PDF ↗ |
| K133561 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH | AngioDynamics, Inc. | 2013-12-19 | Special | PDF ↗ |
| K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS | Cutera, Inc. | 2013-12-06 | Traditional | PDF ↗ |
| K131095 | DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS | El.En Electronic Engineering Spa | 2013-12-05 | Traditional | PDF ↗ |
| K131142 | GENESIS LED WANDS | Genesis Biosystems, Inc. | 2013-11-27 | Traditional | PDF ↗ |
| K130199 | CLARITY LPC LASER SYSTEM | Lutronic Corporation | 2013-11-22 | Traditional | PDF ↗ |
| K131839 | DC 7 | Dc International, LLC | 2013-11-07 | Traditional | PDF ↗ |
| K131894 | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | Nidek Co., Ltd. | 2013-10-31 | Special | PDF ↗ |
| K131473 | (QUANTA SYSTEM) SURGICAL LASER FIBERS | Quanta System Spa | 2013-10-24 | Traditional | PDF ↗ |
| K131059 | PIONEER ELITE DIODE LASER | CAO Group, Inc. | 2013-09-13 | Traditional | PDF ↗ |
| K123443 | PRECISE SHP DIODE LASER | CAO Group, Inc. | 2013-08-13 | Traditional | PDF ↗ |
| K131955 | NEUROBLATE(TM) SYSTEM | Monteris Medical, Inc. | 2013-07-30 | Special | PDF ↗ |
| K131805 | INPULSE LASER | Incisive, Inc. | 2013-07-18 | Special | PDF ↗ |
| K130420 | SOLEA | Convergent Dental, Inc. | 2013-07-12 | Traditional | PDF ↗ |
| K131278 | MONTERIS MEDICAL NEUROBLATE SYSTEM | Monteris Medical, Inc. | 2013-07-11 | Traditional | PDF ↗ |
| K131081 | CYBER TM FAMILY | Quanta System Spa | 2013-07-03 | Traditional | PDF ↗ |
| K130256 | MDK MULTI-APPLICATIONS PLATFORM | Quanta System Spa | 2013-07-02 | Traditional | PDF ↗ |
| K124030 | COOK HOLMIUM LASER FIBER | Cook Incorporated | 2013-07-01 | Special | PDF ↗ |
| K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM | Sciton, Inc | 2013-06-19 | Traditional | PDF ↗ |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | Solta Medical, Inc. | 2013-06-14 | Traditional | PDF ↗ |
| K122020 | PHOTON PHOTON PLUS | Zolar Technology & Mfg Co., Inc. | 2013-06-05 | Traditional | PDF ↗ |
| K130444 | H-30 HOLMIUM LASER SYSTEM | Cook, Inc. | 2013-05-22 | Special | PDF ↗ |
| K122493 | GENESISPLUS | Cutera, Inc. | 2013-05-15 | Traditional | PDF ↗ |
| K130250 | QYAG LASER SYSTEM | Palomar Medical Technologies, Inc. | 2013-05-03 | Traditional | PDF ↗ |
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | Biolase Technology, Inc. | 2013-05-02 | Traditional | PDF ↗ |
| K123483 | DIODE LASER | BEIJING SYNTECH LASER CO., LTD. | 2013-04-21 | Traditional | PDF ↗ |
| K123573 | YOULASER CO2 LASER | Quanta System Spa | 2013-04-15 | Traditional | PDF ↗ |
| K123777 | MULTILASER SYSTEM | Ultralight Laser Technologies, LLC | 2013-04-11 | Traditional | PDF ↗ |
| K130465 | EPIC 10S | Biolase Technology, Inc. | 2013-04-11 | Traditional | PDF ↗ |
| K123293 | PASTELLE Q-SWITCHED ND: YAG LASER | Won Technology Co., Ltd. | 2013-04-11 | Traditional | PDF ↗ |
| K120561 | NEUROBLATE SYSTEM | Monteris Medical, Inc. | 2013-04-01 | Traditional | PDF ↗ |
| K130671 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT | AngioDynamics, Inc. | 2013-03-26 | Special | PDF ↗ |
| K130164 | FIBERLASE ENDURE CO2 FIBER | Lumenis, Ltd. | 2013-03-24 | Special | PDF ↗ |
| K130344 | DORNIER MEDILAS UROPULSE | Dornier Medtech America, Inc. | 2013-03-21 | Special | PDF ↗ |
| K130413 | PINPOINTE FOOTLASER | Nuvolase, Inc. | 2013-03-21 | Special | PDF ↗ |
| K123682 | INMODE HAIR REMOVAL (HR) DEVICE | Inmode MD , Ltd. | 2013-02-27 | Traditional | PDF ↗ |
| K110941 | REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 | Allmed Systems, Inc. | 2013-02-19 | Traditional | PDF ↗ |
| K123494 | SOLEA | Convergent Dental, Inc. | 2013-02-11 | Traditional | PDF ↗ |
| K121327 | DIOLASE 10S | Biolase Technology, Inc. | 2013-02-01 | Traditional | PDF ↗ |
| K113504 | DEKA SMARTXIDE AND DELIVERY ACCESSORIES | El.En Electronic Engineering Spa | 2013-02-01 | Traditional | PDF ↗ |
| K122159 | DORNIER MEDILAS H30 SOLVO | Dornier Medtech America, Inc. | 2013-02-01 | Special | PDF ↗ |
| K122251 | VITRA MULTISPOT | Quantel Medical | 2013-01-24 | Traditional | PDF ↗ |
| K124003 | MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE | Med-Fibers, Inc. | 2013-01-17 | Traditional | PDF ↗ |
| K121570 | AURIGA QI | Starmedtec GmbH | 2013-01-16 | Traditional | PDF ↗ |
| K123004 | MIRA LASERS | Mira Lasers, LLC | 2013-01-15 | Traditional | PDF ↗ |
| K122922 | E-BEAM ND: YAG LASER | Eclipse Aesthetics, LLC | 2013-01-10 | Traditional | PDF ↗ |
| K123168 | Q-PLUS T+ IPL LASER SYSTEM | Quanta System Spa | 2012-12-20 | Traditional | PDF ↗ |
| K113018 | APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM | BEIJING SYNTECH LASER CO., LTD. | 2012-12-14 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.