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 |
|---|---|---|---|
| Oct 29, 2009 | K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM Omniguide, Inc. | GEX |
| Oct 6, 2009 | K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 Biotex, Inc. | GEX |
| Oct 1, 2009 | K083927 | WATERLASE MD Biolase Technology, Inc. | GEX |
| Sep 23, 2009 | K091800 | LIPOEZE LASER ASSISTED ASPIRATION CANNULA Curve Medical | GEX |
| Sep 8, 2009 | K091562 | DOCTOR SMILE A-810 AND B-980 LASERS Lambda Scientific Spa, IT | GEX |
| Sep 3, 2009 | K091537 | CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH Cynosure, Inc. | GEX |
| Aug 28, 2009 | K090762 | LEDA Quantel Derma GmbH, DE | GEX |
| Aug 19, 2009 | K091320 | SPECTRA SP II, SPECTRA DENTA II Lutronic Corporation | GEX |
| Aug 13, 2009 | K091059 | FOXQ 980 LASER A.R.C Laser GmbH | GEX |
| Aug 13, 2009 | K090571 | ALMA LASERS ALEX755 MODULE Alma Lasers , Ltd. | GEX |
| Jul 31, 2009 | K091796 | SOFTLASE PRO, ORTHOLASE AND HYGIENELASE Zap Lasers, LLC | GEX |
| Jul 15, 2009 | K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US Optimedica Corporation | GEX |
| Jul 14, 2009 | K091922 | WATERLASE C100, MODEL 7100104 Biolase Technology, Inc. | GEX |
| Jul 9, 2009 | K091909 | LITHO LASER SYSTEM Quanta System Spa, IT | GEX |
| Jun 29, 2009 | 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., SI | GEX |
| Jun 26, 2009 | K090164 | CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER Biolitec, Inc. | GEX |
| Jun 19, 2009 | K091551 | VARI-LASE PLATINUM BRIGHT TIP LASER FIBER Vascular Solutions, Inc. | GEX |
| Jun 19, 2009 | K090962 | CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM Quanta System Spa, IT | GEX |
| Jun 12, 2009 | K083616 | PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS Patholase, Inc. | GEX |
| Jun 4, 2009 | K091323 | MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) Intermedic Arfran, SA | GEX |
| Jun 2, 2009 | K090776 | MEGAPULSE LASER SYSTEM AND FIBERS Richard Wolf Medical Instruments Corp. | GEX |
| Jun 1, 2009 | K083899 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM Hoya Conbio, Inc. | GEX |
| May 20, 2009 | K090094 | ZELTIQ SYSTEM Zeltiq Aesthetics | GEX |
| May 15, 2009 | K083253 | LOTUS II PULSED ER: YAG LASER SYSTEM Laseroptek Co., Ltd. | GEX |
| May 13, 2009 | K091169 | ELITE MPX LASER SYSTEM WITH CRYO C Cynosure, Inc. | GEX |
| May 4, 2009 | K083733 | LUME 2 SYSTEM, MODEL GA0005000 Lumenis, Ltd. | GEX |
| May 1, 2009 | K081509 | MONTERIS MEDICAL AUTOLITT LASER PROBE Monteris Medical, | GEX |
| Apr 28, 2009 | K083203 | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM Laseroptek Co., Ltd. | GEX |
| Apr 23, 2009 | K083889 | FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY Fotona D.D., SI | GEX |
| Apr 14, 2009 | K090618 | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C Cynosure, Inc. | GEX |
| Apr 14, 2009 | K090297 | BLUESHINE GOLD SERIES Blueshine Srl, IT | GEX |
| Apr 14, 2009 | K083848 | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM Alma Lasers , Ltd., IL | GEX |
| Apr 8, 2009 | K083215 | INCISIVE FAMILY OF INPULSE ND:YAG LASERS Incisive, LLC | GEX |
| Mar 27, 2009 | K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY New Star Lasers, Inc. | GEX |
| Mar 20, 2009 | K082039 | SYNCHRO HP PLATFORM El.En Electronic Engineering Spa, IT | GEX |
| Mar 19, 2009 | K081424 | AFFIRM CO2 AND AFFIRM CO2 HP Cynosure, Inc. | GEX |
| Mar 17, 2009 | K090235 | ELITE MPX LASER SYSTEM WITH XPL HANDPIECE Cynosure, Inc. | GEX |
| Mar 17, 2009 | K083478 | SMOOTHLIPO Eleme Medical, Inc. | GEX |
| Mar 13, 2009 | K083142 | PICASSO LASER SYSTEM Amd Lasers, LLC | GEX |
| Mar 6, 2009 | K090084 | ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE Merit Medical Systems, Inc. | GEX |
| Mar 4, 2009 | K090281 | ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES Accutech Medical Technologies, Inc. | GEX |
| Feb 27, 2009 | K083900 | ERBIUM FRACTIONAL HANDPIECE Palomar Medical Products, Inc. | GEX |
| Feb 23, 2009 | K081541 | DERMABLATE EFFECT Asclepion Laser Technologies GmbH, DE | GEX |
| Feb 13, 2009 | K083165 | PALOMAR ASPIRE LASER PLATFORM Palomar Medical Products, Inc. | GEX |
| Feb 12, 2009 | K083500 | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE Dornier Medtech America, Inc. | GEX |
| Feb 11, 2009 | K090181 | WATERLASE MD Biolase Technology, Inc. | GEX |
| Feb 6, 2009 | K082825 | ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM Energist, Ltd., GB | GEX |
| Feb 4, 2009 | K083034 | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F Fotona D.D., SI | GEX |
| Feb 3, 2009 | K082407 | MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM Sandstone Medical Technologies, LLC | GEX |
| Feb 2, 2009 | K083918 | ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 Advanced Technology Laser Co., Ltd., CN | GEX |
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