Product code GEX— General, Plastic Surgery
NeuroBlate System
- Classification name
- Powered Laser Surgical Instrument
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 2,889
- First cleared
- Most recent
Clearances under product code GEX — page 14
1,301–1,400 of 2,889- K050673 — CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
- K050738 — FT FIBER OPTIC DELIVERY SYSTEMS
- K043377 — ZENO
- K051167 — REVOLIX AND REVOLIX JR
- K050453 — ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
- K050900 — MEDIOSTAR XT
- K050672 — ERCHONIA EVRL LASER
- K050274 — DIODENT II DENTAL LASER SYSTEM
- K050950 — MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
- K041554 — AIP INTENSE PULSED LIGHT SYSTEM
- K050165 — MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
- K050254 — SPECTRA-SP CO2 LASER SYSTEM
- K050562 — OCULIGHT GL/GLX
- K050796 — AURORA DS, DS APPLICATOR
- K050047 — CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
- K050679 — CUTERA SOLERA OPUS AESTHETIC PRODUCT
- K043521 — BIOSYAG 50 MED
- K043329 — OMNILUX REVIVE AND BLUE
- K050021 — VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
- K050293 — FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
- K050108 — SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
- K050412 — VAPORMAX
- K042319 — RELIANT LASER II SYSTEM AND ACCESSORIES
- K050452 — AURORA SR AND SRA APPLICATOR
- K043486 — PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
- K043255 — ELLIPSE LIGHT SPT
- K043575 — DERMILLUME, MODEL PRO1000
- K050317 — BURANE XL
- K050218 — WAVELIGHT SINON
- K043251 — CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
- K043046 — COOLTOUCH, MODEL CT3S
- K043173 — Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
- K050069 — CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
- K040103 — SOUNDSKIN PHOTOTHERAPY SYSTEM
- K041086 — PALOMAR STARLUX PULSED LIGHT SYSTEM
- K041879 — PALOMAR LUX1064 HANDPIECE
- K043429 — CYNERGY LASER
- K042000 — MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
- K043319 — CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
- K040270 — OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
- K031425 — GENTLEWAVES LED PHOTOMODULATION DEVICE
- K041011 — ULTRALIGHT II ND:YAG LASER SYSTEM
- K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
- K043164 — PANALIGHT-BLU, MODEL 4175
- K041957 — EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
- K040744 — ATRILAZE SOFT TISSUE ABLATION SYSTEM
- K042968 — MCL 30 DERMABLATE ER:YAG LASER SYSTEM
- K041242 — CANDELA SMOOTHBEAM LASER SYSTEM
- K042918 — MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
- K041323 — PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
- K043012 — OMNIPULSE MINI, MODEL 2120
- K041959 — POLARIS DS/COMET
- K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
- K042496 — ADEPT ULTRALITE 532 LASER
- K041969 — AURORA DS
- K041943 — XTRAC XL, MODEL AL8000
- K040563 — LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)
- K042439 — AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
- K041994 — MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
- K041767 — COOLCUBE COOLPEN
- K041739 — EDWARDS E360 SURGICAL ABLATION DEVICE
- K042474 — ARION
- K040921 — COOLTOUCH, MODEL NS 160
- K032991 — LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
- K041930 — VARILITE LASER SYSTEM
- K042139 — VISULAS YAG III
- K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS
- K041829 — FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
- K041419 — LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
- K041262 — DURALITE-GL
- K041721 — LVI AESTHETIC LASER
- K041710 — VERSAWAVE DENTAL ER:YAG LASER SYSTEM
- K041103 — ACNELIFT
- K030290 — PERIOLASE ND:YAG DENTAL LASER SYSTEM
- K031140 — WATERLASE
- K041569 — CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
- K040617 — RELIANT LASER SYSTEM II
- K040659 — MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
- K032397 — DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
- K041095 — PHOTOSILK PULSED LIGHT SYSTEM
- K040433 — SINON
- K040384 — MYDON C
- K040424 — LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
- K030810 — COOLAN 300
- K040294 — LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
- K040289 — SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
- K040727 — CRYO 5
- K040131 — COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
- K033183 — RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
- K040055 — POLYLASE LP
- K032797 — DELIGHT DENTAL ER: YAG LASER SYSTEM
- K040234 — LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
- K033072 — LUCENTLITE, MODEL IMD 010
- K040081 — PALOMAR LUXV HANDPIECE
- K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
- K040005 — PROFILE 2000/3000 LASER SYSTEM
- K040156 — IFL PROFESSIONAL SYSTEM, MODEL C100
- K032863 — CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
- K032864 — CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
- K033933 — POWERLITE 600 EX SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.