Panels › General, Plastic Surgery › Product code GEX · Class 2
Powered Laser Surgical Instrument
Regulation 878.4810
69510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
Top companies in GEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cynosure, Inc. | 84 | 1 |
| Lumenis | 60 | 11 |
| Sharplan Lasers, Inc. | 66 | 0 |
| Quanta System Spa | 57 | 6 |
| Candela Corp. | 53 | 5 |
| Laserscope | 49 | 0 |
| Trimedyne, Inc. | 48 | 0 |
| Heraeus Lasersonics, Inc. | 37 | 0 |
| Surgical Laser Technologies, Inc. | 35 | 0 |
| Boston Scientific | 11 | 23 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2014 | K133158 | ND: YAG LASER SYSTEM Beijing Toplaser Technology Co., Ltd., CN | GEX |
| Jan 23, 2014 | K132989 | SPEED 808 DIODE LASER SYSTEM Beijing Toplaser Technology Co., Ltd., CN | GEX |
| Jan 22, 2014 | K132286 | HYPERION LONG PULSED ND: YAG LASER Scarlet Rf, Inc. | GEX |
| Jan 22, 2014 | K131837 | CO2 FRACTIONAL LASER Beijing Honkon Technologies Co., Ltd., CN | GEX |
| Jan 16, 2014 | K131857 | Q-SWITCHED ND:YAG LASER Beijing Honkon Technologies Co., Ltd., CN | GEX |
| Jan 8, 2014 | K130681 | ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER Biolitec Sia | GEX |
| Jan 2, 2014 | K132661 | LIGHTSCALPEL Lightscalpel, LLC | GEX |
| Dec 26, 2013 | K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| Dec 19, 2013 | K133561 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH AngioDynamics, Inc. | GEX |
| Dec 6, 2013 | K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS Cutera, Inc. | GEX |
| Dec 5, 2013 | K131095 | DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS El.En Electronic Engineering Spa, IT | GEX |
| Nov 27, 2013 | K131142 | GENESIS LED WANDS Genesis Biosystems, Inc. | GEX |
| Nov 22, 2013 | K130199 | CLARITY LPC LASER SYSTEM Lutronic Corporation | GEX |
| Nov 7, 2013 | K131839 | DC 7 Dc International, LLC | GEX |
| Oct 31, 2013 | K131894 | NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT Nidek Co., Ltd., JP | GEX |
| Oct 24, 2013 | K131473 | (QUANTA SYSTEM) SURGICAL LASER FIBERS Quanta System Spa, IT | GEX |
| Sep 13, 2013 | K131059 | PIONEER ELITE DIODE LASER CAO Group, Inc. | GEX |
| Aug 13, 2013 | K123443 | PRECISE SHP DIODE LASER CAO Group, Inc. | GEX |
| Jul 30, 2013 | K131955 | NEUROBLATE(TM) SYSTEM Monteris Medical, Inc. | GEX |
| Jul 18, 2013 | K131805 | INPULSE LASER Incisive, Inc. | GEX |
| Jul 12, 2013 | K130420 | SOLEA Convergent Dental, Inc. | GEX |
| Jul 11, 2013 | K131278 | MONTERIS MEDICAL NEUROBLATE SYSTEM Monteris Medical, Inc. | GEX |
| Jul 3, 2013 | K131081 | CYBER TM FAMILY Quanta System Spa, IT | GEX |
| Jul 2, 2013 | K130256 | MDK MULTI-APPLICATIONS PLATFORM Quanta System Spa, IT | GEX |
| Jul 1, 2013 | K124030 | COOK HOLMIUM LASER FIBER Cook Incorporated | GEX |
| Jun 19, 2013 | K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM Sciton, Inc | GEX |
| Jun 14, 2013 | K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM Solta Medical, Inc. | GEX |
| Jun 5, 2013 | K122020 | PHOTON PHOTON PLUS Zolar Technology & Mfg Co., Inc. | GEX |
| May 22, 2013 | K130444 | H-30 HOLMIUM LASER SYSTEM Cook, Inc. | GEX |
| May 15, 2013 | K122493 | GENESISPLUS Cutera, Inc. | GEX |
| May 3, 2013 | K130250 | QYAG LASER SYSTEM Palomar Medical Technologies, Inc. | GEX |
| May 2, 2013 | K122368 | WATERLASE IPLUS ALL TISSUE LASER Biolase Technology, Inc. | GEX |
| Apr 21, 2013 | K123483 | DIODE LASER BEIJING SYNTECH LASER CO., LTD., CN | GEX |
| Apr 15, 2013 | K123573 | YOULASER CO2 LASER Quanta System Spa, IT | GEX |
| Apr 11, 2013 | K130465 | EPIC 10S Biolase Technology, Inc. | GEX |
| Apr 11, 2013 | K123777 | MULTILASER SYSTEM Ultralight Laser Technologies, LLC | GEX |
| Apr 11, 2013 | K123293 | PASTELLE Q-SWITCHED ND: YAG LASER Won Technology Co., Ltd. | GEX |
| Apr 1, 2013 | K120561 | NEUROBLATE SYSTEM Monteris Medical, Inc., CA | GEX |
| Mar 26, 2013 | K130671 | VENACURE EVLT NEVERTOUCH PROCEDURE KIT AngioDynamics, Inc. | GEX |
| Mar 24, 2013 | K130164 | FIBERLASE ENDURE CO2 FIBER Lumenis, Ltd., IL | GEX |
| Mar 21, 2013 | K130413 | PINPOINTE FOOTLASER Nuvolase, Inc. | GEX |
| Mar 21, 2013 | K130344 | DORNIER MEDILAS UROPULSE Dornier Medtech America, Inc. | GEX |
| Feb 27, 2013 | K123682 | INMODE HAIR REMOVAL (HR) DEVICE Inmode MD , Ltd., IL | GEX |
| Feb 19, 2013 | K110941 | REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 Allmed Systems, Inc. | GEX |
| Feb 11, 2013 | K123494 | SOLEA Convergent Dental, Inc. | GEX |
| Feb 1, 2013 | K122159 | DORNIER MEDILAS H30 SOLVO Dornier Medtech America, Inc. | GEX |
| Feb 1, 2013 | K121327 | DIOLASE 10S Biolase Technology, Inc. | GEX |
| Feb 1, 2013 | K113504 | DEKA SMARTXIDE AND DELIVERY ACCESSORIES El.En Electronic Engineering Spa, IT | GEX |
| Jan 24, 2013 | K122251 | VITRA MULTISPOT Quantel Medical | GEX |
| Jan 17, 2013 | K124003 | MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE Med-Fibers, Inc. | GEX |
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