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 |
|---|---|---|---|
| Nov 6, 2014 | K140727 | CUTERA PICOSECOND LASER SYSTEM Cutera, Inc. | GEX |
| Oct 31, 2014 | K142286 | NS3000 Holmium Laser System New Star Lasers, Inc. | GEX |
| Oct 30, 2014 | K142372 | Pico Way Laser System Candela Corpation | GEX |
| Oct 22, 2014 | K141908 | DUAL SWITCH Laser Engineering, Inc. | GEX |
| Oct 22, 2014 | K141658 | LIGHT SCALPEL Lightscalpel, LLC | GEX |
| Oct 15, 2014 | K140470 | OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER Oberon GmbH Fiber Technologies | GEX |
| Oct 15, 2014 | K131987 | MULTIPULSE HOPLUS Asclepion Laser Technologies GmbH, DE | GEX |
| Oct 10, 2014 | K142614 | AngioDynamics VenaCure EVLT Tre Sheath and VenaCure EVLT NeverTouch Procedure Kits AngioDynamics, Inc. | GEX |
| Oct 10, 2014 | K140120 | EPIC 10 Biolase, Inc. | GEX |
| Oct 8, 2014 | K140249 | LONG PULSE ND: YAG LASER SYSTEM Advanced Technology Laser Co., Ltd., CN | GEX |
| Oct 6, 2014 | K141973 | DIODE LASER HAIR REMOVAL SYSTEM Beijing Anchorfree Technology Co., Ltd., CN | GEX |
| Sep 25, 2014 | K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT Omniguide, Inc. | GEX |
| Sep 24, 2014 | K142376 | Palomar Icon Aesthetic System Cynosure, Inc. | GEX |
| Sep 24, 2014 | K140837 | LUCID LY Bio-Med USA, Inc. | GEX |
| Sep 22, 2014 | K140719 | PICOSURE WORKSTATION Cynosure, Inc. | GEX |
| Sep 12, 2014 | K142226 | Pilot Ultra Diode Laser CAO Group, Inc. | GEX |
| Sep 12, 2014 | K142225 | Pilot Elite Diode Laser CAO Group, Inc. | GEX |
| Sep 12, 2014 | K142223 | Pilot Pro Diode Laser CAO Group, Inc. | GEX |
| Sep 11, 2014 | K141425 | ELITE + LASER SYSTEM Cynosure, Inc. | GEX |
| Sep 5, 2014 | K133895 | DEKA SMARTXIDE LASER SYSTEM El.En S.P.A. | GEX |
| Sep 4, 2014 | K140964 | CALCULASE II KARL STORZ Endoscopy-America, Inc. | GEX |
| Aug 29, 2014 | K140009 | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM Alma Lasers , Ltd. | GEX |
| Aug 26, 2014 | K140458 | DIOTECH LASER FIBER Diotech CO | GEX |
| Aug 15, 2014 | K140366 | ENDLESSFIBER REUSABLE SURGICAL LASER FIBER Hogue Surgical, LLC | GEX |
| Aug 11, 2014 | K141983 | NEUROBLATE SYSTEM Monteris Medical Corp. | GEX |
| Aug 11, 2014 | K133945 | CUTERA PICOSECOND LASER SYSTEM Cutera, Inc. | GEX |
| Aug 8, 2014 | K141101 | LITHO Quanta System Spa, IT | GEX |
| Aug 7, 2014 | K141403 | LITHO DK30 Quanta System Spa, IT | GEX |
| Jul 25, 2014 | K141838 | SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) Regulatory Technology Services, LLC | GEX |
| Jul 22, 2014 | K133364 | PICOSURE WORKSTATION Cynosure, Inc. | GEX |
| Jul 18, 2014 | K140005 | ALMA DIODE TABLETOP LASER Alma Lasers , Ltd. | GEX |
| Jul 17, 2014 | K131757 | TATTOOSTAR EFFECT COMBO Asclepion Laser Technologies GmbH, DE | GEX |
| Jul 15, 2014 | K141063 | LINSCAN 808, LINSCAN 980 Gme (German Medical Engineering) GmbH | GEX |
| Jul 11, 2014 | K132806 | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE Fotona D.D., SI | GEX |
| Jun 20, 2014 | K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS American Medical Systems | GEX |
| Jun 10, 2014 | K133297 | QUADROSTARPROGREEN, QUADROSTARPROYELLOW Asclepion Laser Technologies GmbH, DE | GEX |
| Jun 6, 2014 | K133774 | ATOVEN Bio-Med USA, Inc. | GEX |
| May 9, 2014 | K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM Candela Corp. | GEX |
| Apr 24, 2014 | K131838 | DIODE LASER FOR HIAR REMOVAL Beijing Honkon Technologies Co., Ltd., CN | GEX |
| Apr 18, 2014 | K133915 | GALAXY CO2 LASER SYSTEM Beijing Toplaser Technology Co., Ltd., CN | GEX |
| Apr 17, 2014 | K133006 | NEOV DIODE LASER FAMILY G.N.S Neolaser , Ltd., IL | GEX |
| Apr 17, 2014 | K132976 | ADVATX Advalight Aps | GEX |
| Apr 15, 2014 | K140503 | FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER Boston Scientific | GEX |
| Apr 9, 2014 | K133837 | VIORA V-TOTAL Viora , Ltd., IL | GEX |
| Mar 21, 2014 | K132607 | NS 2500 HOLMIUM LASER SYSTEM New Star Lasers, Inc. | GEX |
| Mar 20, 2014 | K133319 | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 Lumenis, Ltd., IL | GEX |
| Mar 18, 2014 | K132975 | SPHINX JR Allmed Systems, Inc. | GEX |
| Mar 14, 2014 | K140388 | LUMENIS PULSE 120H Lumenis, Ltd., IL | GEX |
| Mar 11, 2014 | K122358 | NOVEON Hogan Lovells US LLP | GEX |
| Mar 5, 2014 | K133254 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM Cynosure, Inc. | GEX |
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