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 |
|---|---|---|---|
| Dec 22, 2015 | K150997 | RUBY STAR Bison Medical Co, Ltd., KR | GEX |
| Dec 22, 2015 | K150664 | NeoLas Sheaumann Laser, Inc. | GEX |
| Dec 21, 2015 | K152714 | Quanta Forte Quanta System Spa, IT | GEX |
| Dec 17, 2015 | K152636 | Laser Dock Patient Pocket, LLC | GEX |
| Dec 11, 2015 | K152153 | MicroSpot Handpiece Asclepion Laser Technologies GmbH, DE | GEX |
| Dec 8, 2015 | K152722 | neoV980 & neoV1470 Diode Lasers G.N.S Neolaser , Ltd., IL | GEX |
| Dec 8, 2015 | K152012 | EVO platform Quanta System Spa, IT | GEX |
| Dec 1, 2015 | K152417 | Adler MicroMed Laser Surgery Fibers Adler Micromed, Inc. | GEX |
| Nov 25, 2015 | K152939 | Picasso Plus, Picasso Lite Plus Amd Group, LLC | GEX |
| Oct 30, 2015 | K151109 | Lumenis Smart532 Laser System Lumenis, Inc. | GEX |
| Oct 27, 2015 | K151629 | Guardian 1000 Quanta System Spa, IT | GEX |
| Oct 8, 2015 | K152591 | Medilas H RFID Laser Fibers Dornier Medtech America, Inc. | GEX |
| Sep 23, 2015 | K151306 | Solea Convergent Dental, Inc. | GEX |
| Sep 16, 2015 | K152032 | ELUMI 810 + 980 Soft Tissue Laser Azena Medical, LLC | GEX |
| Sep 15, 2015 | K151655 | CO2RE System Syneron Medical, Ltd., IL | GEX |
| Sep 3, 2015 | K152220 | MH01 Quanta System Spa, IT | GEX |
| Sep 1, 2015 | K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module Focus Medical, LLC | GEX |
| Aug 12, 2015 | K151947 | LightSheer Desire Light Laser System Lumenis, Ltd., IL | GEX |
| Aug 6, 2015 | K151232 | VIKINI Diode Laser System Ilooda Co,., Ltd., KR | GEX |
| Jul 21, 2015 | K150587 | Cortex Laser System Cynosure, Inc. Dba Ellman | GEX |
| Jul 7, 2015 | K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra Ellipse A/S, DK | GEX |
| Jun 30, 2015 | K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTo Lumenis, Ltd., IL | GEX |
| Jun 5, 2015 | K150140 | MCL 31 Dermablate Asclepion Laser Technologies GmbH, DE | GEX |
| May 26, 2015 | K140386 | LUMINA 24 Rogers Sciences, Inc. | GEX |
| Apr 23, 2015 | K143666 | Noblex Long Pulse Alexandrite Laser Finemec Co., Ltd., KR | GEX |
| Apr 21, 2015 | K142216 | Tranberg CLS Thermal Therapy System Clinical Laserthermia Systems, AB, SE | GEX |
| Apr 17, 2015 | K142186 | DIODE LASER HAIR REMOVAL SYSTEM Shenzhen Gsd Tech Co., Ltd., CN | GEX |
| Apr 16, 2015 | K150326 | PicoWay Laser System Candela Corporation | GEX |
| Apr 13, 2015 | K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS El.En Electronic Engineering Spa, IT | GEX |
| Apr 9, 2015 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro Fotona D.D., SI | GEX |
| Apr 3, 2015 | K150027 | CYMA Whitecap Technologies, LLC | GEX |
| Mar 18, 2015 | K133788 | COOK HOLMIUM LASER FIBER Cook Incorporated | GEX |
| Mar 10, 2015 | K143519 | The MeDioStar NeXT Family Asclepion Laser Technologies GmbH, DE | GEX |
| Mar 5, 2015 | K141975 | WATERLASE IPLUS S Biolase, Inc. | GEX |
| Feb 24, 2015 | K150336 | Photonica Professional Ward Photonics, LLC | GEX |
| Feb 23, 2015 | K143105 | Picosure Workstation Cynosure, Inc. | GEX |
| Feb 19, 2015 | K143457 | NeuroBlate System Monteris Medical, Inc. | GEX |
| Feb 13, 2015 | K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family Shaser, Inc. | GEX |
| Jan 30, 2015 | K141986 | ELUX 810 LASER Equipmed North America, Inc. | GEX |
| Jan 30, 2015 | K133891 | MULTIPULSE TM+1470 Asclepion Laser Technologies GmbH, DE | GEX |
| Jan 23, 2015 | K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS Cynosure, Inc. | GEX |
| Jan 21, 2015 | K142860 | Lumenis M22 System Lumenis, Ltd., IL | GEX |
| Jan 13, 2015 | K142952 | InMode Diolaze Device Inmode MD , Ltd., IL | GEX |
| Jan 6, 2015 | K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM Amo Manufacturing USA, LLC | GEX |
| Jan 2, 2015 | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) Iridex Corporation | GEX |
| Jan 2, 2015 | K141851 | NAVILAS LASER SYSTEM Od-Os GmbH | GEX |
| Dec 19, 2014 | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) Innovaquartz, LLC | GEX |
| Nov 14, 2014 | K142093 | V20 SYSTEM Viora , Ltd., IL | GEX |
| Nov 7, 2014 | K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| Nov 6, 2014 | K141555 | ADVANTAGE Lutronic Corporation | GEX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.