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 7 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162914 | VenaCure EVLT NeverTouch Procedure Kit | AngioDynamics, Inc. | 2016-11-16 | Special | PDF ↗ |
| K162781 | Magma Spark | Formatk Systems , Ltd. | 2016-11-09 | Special | PDF ↗ |
| K161670 | Lucid Q-PTP / HWA 55 | Bison Medical Co, Ltd. | 2016-11-02 | Traditional | PDF ↗ |
| K160488 | Cutera enlighten III Laser System | Cutera, Inc. | 2016-10-28 | Traditional | PDF ↗ |
| K160312 | FRAXIS DUO | Ilooda Co,., Ltd. | 2016-10-28 | Traditional | PDF ↗ |
| K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016-10-27 | Traditional | PDF ↗ |
| K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016-10-26 | Special | PDF ↗ |
| K161981 | Olive Plus | Ama Network, Inc. | 2016-10-14 | Traditional | PDF ↗ |
| K161925 | CO2 Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2016-10-05 | Traditional | PDF ↗ |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | Iridex Corporation | 2016-09-29 | Special | PDF ↗ |
| K161185 | LUCERNA Dental Laser | Viax Dental Lab | 2016-09-26 | Traditional | PDF ↗ |
| K160413 | Sterling 5W Diode Laser | CAO Group, Inc. | 2016-09-21 | Traditional | PDF ↗ |
| K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | Ellipse A/S | 2016-09-16 | Traditional | PDF ↗ |
| K161356 | Matrix LS-40 CO2 Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2016-09-09 | Traditional | PDF ↗ |
| K161503 | ORION | Yerim Engineering Co., Ltd. | 2016-08-26 | Traditional | PDF ↗ |
| K161403 | A.R.C. Laser Surgical Fibers and Probes | A.R.C Laser GmbH | 2016-08-16 | Traditional | PDF ↗ |
| K161771 | Medilas H Laser Fibers | Dornier Medtech America, Inc. | 2016-07-28 | Special | PDF ↗ |
| K161669 | Waterlase Express | Biolase, Inc. | 2016-07-28 | Traditional | PDF ↗ |
| K153124 | DuraLazeTM HoLEP Laser Fiber | Medkey, LLC | 2016-07-26 | Traditional | PDF ↗ |
| K160607 | PicoWay Laser System | Syneron Candela Corporation | 2016-07-05 | Traditional | PDF ↗ |
| K152737 | Lite Touch | Focus Medical, LLC | 2016-06-29 | Traditional | PDF ↗ |
| K152667 | ATOVEN-Reusable Laser Fiber | Diotech CO | 2016-06-09 | Traditional | PDF ↗ |
| K152856 | Helios III | Laseroptek Co., Ltd. | 2016-06-02 | Traditional | PDF ↗ |
| K160012 | O-pel Laser and families of probe delivery devices | Precise Light Surgical | 2016-06-02 | Traditional | PDF ↗ |
| K160480 | PicoSure Workstation | Cynosure, Inc. | 2016-05-17 | Traditional | PDF ↗ |
| K160952 | Alma Diode Tabletop Laser | Alma, Ltd. | 2016-05-05 | Special | PDF ↗ |
| K160227 | ACCENTO / HWA Dual/Single laser | Bison Medical Co, Ltd. | 2016-04-22 | Traditional | PDF ↗ |
| K151855 | SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber | Surgical Laser Incorporated | 2016-04-15 | Traditional | PDF ↗ |
| K153229 | Superbium | Bios S.R.L. | 2016-04-12 | Traditional | PDF ↗ |
| K153566 | Magma System | Formatk Systems , Ltd. | 2016-04-06 | Traditional | PDF ↗ |
| K160368 | EVO platform | Quanta System Spa | 2016-04-05 | Special | PDF ↗ |
| K153564 | PURE CRYOGEN | Air Liquide Healthcare America Corporation | 2016-03-29 | Traditional | PDF ↗ |
| K160513 | Quanta System Surgical Laser fibers | Quanta System Spa | 2016-03-18 | Special | PDF ↗ |
| K151763 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2016-03-15 | Traditional | PDF ↗ |
| K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016-03-09 | Traditional | PDF ↗ |
| K153527 | PicoWay Laser System | Syneron Candela Corporation | 2016-03-02 | Traditional | PDF ↗ |
| K160392 | Novilase Laser Therapy System, Model LTS-2 | Novian Health, Inc. | 2016-02-26 | Special | PDF ↗ |
| K152736 | SKIN CARE | C.I.S, Ltd. | 2016-02-25 | Traditional | PDF ↗ |
| K152611 | V20 system | Viora , Ltd. | 2016-02-19 | Traditional | PDF ↗ |
| K153718 | Spirit Hair Removal laser Family | Active Optical Systems , Ltd. | 2016-02-12 | Traditional | PDF ↗ |
| K151569 | Tranberg CLS Laser Fiber | Clinical Laserthermia Systems, AB | 2016-02-12 | Traditional | PDF ↗ |
| K152898 | DIODE LASER THERAPY SYSTEMS | Beijing Sincoheren Science and Tech. Development Co., Ltd. | 2016-02-09 | Traditional | PDF ↗ |
| K152529 | NaturaLase CO2 Laser System | Focus Medical, LLC | 2016-02-04 | Abbreviated | PDF ↗ |
| K143713 | Lustre PRO Light System | Ambicare Health, Ltd. | 2016-01-19 | Traditional | PDF ↗ |
| K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015-12-23 | Traditional | PDF ↗ |
| K150664 | NeoLas | Sheaumann Laser, Inc. | 2015-12-22 | Traditional | PDF ↗ |
| K150997 | RUBY STAR | Bison Medical Co, Ltd. | 2015-12-22 | Traditional | PDF ↗ |
| K152714 | Quanta Forte | Quanta System Spa | 2015-12-21 | Traditional | PDF ↗ |
| K152636 | Laser Dock | Patient Pocket, LLC | 2015-12-17 | Traditional | PDF ↗ |
| K152153 | MicroSpot Handpiece | Asclepion Laser Technologies GmbH | 2015-12-11 | Traditional | PDF ↗ |
| K152012 | EVO platform | Quanta System Spa | 2015-12-08 | Traditional | PDF ↗ |
| K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser , Ltd. | 2015-12-08 | Traditional | PDF ↗ |
| K152417 | Adler MicroMed Laser Surgery Fibers | Adler Micromed, Inc. | 2015-12-01 | Traditional | PDF ↗ |
| K152939 | Picasso Plus, Picasso Lite Plus | Amd Group, LLC | 2015-11-25 | Special | PDF ↗ |
| K151109 | Lumenis Smart532 Laser System | Lumenis, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K151629 | Guardian 1000 | Quanta System Spa | 2015-10-27 | Traditional | PDF ↗ |
| K152591 | Medilas H RFID Laser Fibers | Dornier Medtech America, Inc. | 2015-10-08 | Special | PDF ↗ |
| K151306 | Solea | Convergent Dental, Inc. | 2015-09-23 | Traditional | PDF ↗ |
| K152032 | ELUMI 810 + 980 Soft Tissue Laser | Azena Medical, LLC | 2015-09-16 | Traditional | PDF ↗ |
| K151655 | CO2RE System | Syneron Medical, Ltd. | 2015-09-15 | Traditional | PDF ↗ |
| K152220 | MH01 | Quanta System Spa | 2015-09-03 | Special | PDF ↗ |
| K151473 | NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module | Focus Medical, LLC | 2015-09-01 | Traditional | PDF ↗ |
| K151947 | LightSheer Desire Light Laser System | Lumenis, Ltd. | 2015-08-12 | Special | PDF ↗ |
| K151232 | VIKINI Diode Laser System | Ilooda Co,., Ltd. | 2015-08-06 | Traditional | PDF ↗ |
| K150587 | Cortex Laser System | Cynosure, Inc. Dba Ellman | 2015-07-21 | Traditional | PDF ↗ |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | Ellipse A/S | 2015-07-07 | Traditional | PDF ↗ |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch | Lumenis, Ltd. | 2015-06-30 | Special | PDF ↗ |
| K150140 | MCL 31 Dermablate | Asclepion Laser Technologies GmbH | 2015-06-05 | Traditional | PDF ↗ |
| K140386 | LUMINA 24 | Rogers Sciences, Inc. | 2015-05-26 | Traditional | PDF ↗ |
| K143666 | Noblex Long Pulse Alexandrite Laser | Finemec Co., Ltd. | 2015-04-23 | Traditional | PDF ↗ |
| K142216 | Tranberg CLS Thermal Therapy System | Clinical Laserthermia Systems, AB | 2015-04-21 | Traditional | PDF ↗ |
| K142186 | DIODE LASER HAIR REMOVAL SYSTEM | Shenzhen Gsd Tech Co., Ltd. | 2015-04-17 | Traditional | PDF ↗ |
| K150326 | PicoWay Laser System | Candela Corporation | 2015-04-16 | Traditional | PDF ↗ |
| K150516 | DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS | El.En Electronic Engineering Spa | 2015-04-13 | Special | PDF ↗ |
| K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015-04-09 | Traditional | PDF ↗ |
| K150027 | CYMA | Whitecap Technologies, LLC | 2015-04-03 | Traditional | PDF ↗ |
| K133788 | COOK HOLMIUM LASER FIBER | Cook Incorporated | 2015-03-18 | Traditional | PDF ↗ |
| K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015-03-10 | Special | PDF ↗ |
| K141975 | WATERLASE IPLUS S | Biolase, Inc. | 2015-03-05 | Traditional | PDF ↗ |
| K150336 | Photonica Professional | Ward Photonics, LLC | 2015-02-24 | Traditional | PDF ↗ |
| K143105 | Picosure Workstation | Cynosure, Inc. | 2015-02-23 | Traditional | PDF ↗ |
| K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015-02-19 | Special | PDF ↗ |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family | Shaser, Inc. | 2015-02-13 | Traditional | PDF ↗ |
| K141986 | ELUX 810 LASER | Equipmed North America, Inc. | 2015-01-30 | Traditional | PDF ↗ |
| K133891 | MULTIPULSE TM+1470 | Asclepion Laser Technologies GmbH | 2015-01-30 | Traditional | PDF ↗ |
| K141511 | SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS | Cynosure, Inc. | 2015-01-23 | Traditional | PDF ↗ |
| K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015-01-21 | Traditional | PDF ↗ |
| K142952 | InMode Diolaze Device | Inmode MD , Ltd. | 2015-01-13 | Traditional | PDF ↗ |
| K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM | Amo Manufacturing USA, LLC | 2015-01-06 | Traditional | PDF ↗ |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | Iridex Corporation | 2015-01-02 | Special | PDF ↗ |
| K141851 | NAVILAS LASER SYSTEM | Od-Os GmbH | 2015-01-02 | Traditional | PDF ↗ |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | Innovaquartz, LLC | 2014-12-19 | Traditional | PDF ↗ |
| K142093 | V20 SYSTEM | Viora , Ltd. | 2014-11-14 | Traditional | PDF ↗ |
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Candela Corp. | 2014-11-07 | Special | PDF ↗ |
| K141555 | ADVANTAGE | Lutronic Corporation | 2014-11-06 | Traditional | PDF ↗ |
| K140727 | CUTERA PICOSECOND LASER SYSTEM | Cutera, Inc. | 2014-11-06 | Traditional | PDF ↗ |
| K142286 | NS3000 Holmium Laser System | New Star Lasers, Inc. | 2014-10-31 | Special | PDF ↗ |
| K142372 | Pico Way Laser System | Candela Corpation | 2014-10-30 | Traditional | PDF ↗ |
| K141908 | DUAL SWITCH | Laser Engineering, Inc. | 2014-10-22 | Special | PDF ↗ |
| K141658 | LIGHT SCALPEL | Lightscalpel, LLC | 2014-10-22 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.