Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HLDEngine, Trephine, Accessories, Gas-Powered1Product Code
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered2Product Code
- FCTHeadlight, Fiberoptic Focusing2Product Code
- FSRLight, Headband, Surgical2Product Code
- FTZLocator, Magnetic1Product Code
- HMQMarker, Sclera1Product Code
- HMRMarker, Ocular1Product Code
- HMSDrum, Eye Knife Test1Product Code
- HMXCannula, Ophthalmic1Product Code
- HMYKeratome, Battery-Powered1Product Code
- HMZTrabeculotome1Product Code
- HNASpud, Ophthalmic1Product Code
- HNBSpoon, Ophthalmic1Product Code
- HNCSpecula, Ophthalmic1Product Code
- HNDSpatula, Ophthalmic1Product Code
- HNESnare, Enucleating1Product Code
- HNFScissors, Ophthalmic1Product Code
- HNGRongeur, Lachrymal Sac1Product Code
- HNHRing, Ophthalmic (Flieringa)1Product Code
- HNIRetractor, Ophthalmic1Product Code
- HNJPunch, Corneo-Scleral1Product Code
- HNKProbe, Trabeculotomy1Product Code
- HNLProbe, Lachrymal1Product Code
- HNMNeedle, Ophthalmic Suturing1Product Code
- HNNKnife, Ophthalmic1Product Code
- HNOKeratome, Ac-Powered1Product Code
- HNPIntroducer, Sphere1Product Code
- HNQHook, Ophthalmic1Product Code
- HNRForceps, Ophthalmic1Product Code
- HNSExpressor1Product Code
- HNTErisophake1Product Code
- HNWDilator, Lachrymal1Product Code
- HNXDepressor, Orbital1Product Code
- HNYCystotome1Product Code
- HNZCurette, Ophthalmic1Product Code
- HOACompressor, Orbital1Product Code
- HOBClamp, Muscle, Ophthalmic1Product Code
- HOCClip, Iris Retractor1Product Code
- HODClamp, Eyelid, Ophthalmic1Product Code
- HOECaliper, Ophthalmic1Product Code
- HOFBurr, Corneal, Manual1Product Code
- HOGBurr, Corneal, Battery-Powered1Product Code
- HOHSpectacle, Operating (Loupe), Ophthalmic1Product Code
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1Product Code
- HOZSponge, Ophthalmic2Product Code
- HPMLocator, Metal, Electronic2Product Code
- HPNMagnet, Permanent1Product Code
- HPOMagnet, Ac-Powered2Product Code
- HPPHeadlamp, Operating, Battery-Operated1Product Code
- HPQHeadlamp, Operating, Ac-Powered2Product Code
- HPSUnit, Cryophthalmic2Product Code
- HPYUnit, Electrolysis, Battery-Powered, Ophthalmic1Product Code
- HQAUnit, Cryotherapy, Ophthalmic2Product Code
- HQBPhotocoagulator And Accessories2Product Code
- HQCUnit, Phacofragmentation2Product Code
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2Product Code
- HQFLaser, Ophthalmic2Product Code
- K251772Navilas Laser System 577sl (156691)2Cleared 510(K)
- K243014EyeQ nanoECP2Cleared 510(K)
- K240615Leos Laser and Endoscopy System2Cleared 510(K)
- K242397LYNX Photocoagulator2Cleared 510(K)
- K233911VISULAS combi2Cleared 510(K)
- K232417MR Q; MR Q SUPINE; MR Q SLT2Cleared 510(K)
- K230722Eagle device2Cleared 510(K)
- K232051VISULAS green2Cleared 510(K)
- K230350VISULAS yag2Cleared 510(K)
- K231011Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse2Cleared 510(K)
- K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)2Cleared 510(K)
- K220974R:GEN2Cleared 510(K)
- K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)2Cleared 510(K)
- K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo2Cleared 510(K)
- K222157ECHO Photocoagulator2Cleared 510(K)
- K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems2Cleared 510(K)
- K220430Capsulo2Cleared 510(K)
- K213592Iridex 810 Laser2Cleared 510(K)
- K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo2Cleared 510(K)
- K203130Ophthalmic Yag Laser System YC-2002Cleared 510(K)
- K202760Iridex 810 Laser2Cleared 510(K)
- K201623LION Photocoagulator2Cleared 510(K)
- K201502Vitra 8102Cleared 510(K)
- K192045Ophthalmic Yag Laser System YC-2002Cleared 510(K)
- K190448LightLas Pattern Scanning System - TruScan Pro2Cleared 510(K)
- K190083Leaf Photocoagulator2Cleared 510(K)
- K181682VISULAS green2Cleared 510(K)
- K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar2Cleared 510(K)
- K171488PSLT for PASCAL Streamline2Cleared 510(K)
- K170067Easyret2Cleared 510(K)
- K170302YELLOW LASER PHOTOCOAGULATOR YLC-5002Cleared 510(K)
- K153769R:GEN Laser System2Cleared 510(K)
- K152688LightLas Multi-Wavelength Medical Laser System2Cleared 510(K)
- K152603Green Laser Photocoagulator GYC-5002Cleared 510(K)
- K142398Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow2Cleared 510(K)
- K142830Ophthalmed Bending Laser Probes2Cleared 510(K)
- K142172LIGHTMED TRUSCAN 5772Cleared 510(K)
- K133019FIBERION OPHTHALMIC ENDOLASER PROBE2Cleared 510(K)
- K140362KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES2Cleared 510(K)
- K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT2Cleared 510(K)
- K140336OPTIMUS FUSION: SLT, YAG AND YAG/SLT2Cleared 510(K)
- K130195SCANNING LASERLINK2Cleared 510(K)
- K131207FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER2Cleared 510(K)
- K124043LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM2Cleared 510(K)
- K130933SOLUTIS2Cleared 510(K)
- K122202ELLEX 2RT2Cleared 510(K)
- K123542PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER2Cleared 510(K)
- K123056PASCAL LASER INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K121187KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES2Cleared 510(K)
- K120825SUPRA SCAN DELIVERY SYSTEM2Cleared 510(K)
- K111460OPTO HYALUS GREEN LASER2Cleared 510(K)
- K112154FEMTO LDV2Cleared 510(K)
- K111643OPTO MITRA YELLOW LASER2Cleared 510(K)
- K103547LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM2Cleared 510(K)
- K111108PASCAL STREAMLINE 577 (WITH ACCESSORIES)2Cleared 510(K)
- K103056VISULAS TRION LASER SYSTEM WITH THE VITE OPTION2Cleared 510(K)
- K100253VISUMAX LASER KERATOME2Cleared 510(K)
- K100019PASCAL STREAMLINE PHOTOCOAGULATOR2Cleared 510(K)
- K091064NAVILAS LASER SYSTEM2Cleared 510(K)
- K091981LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER2Cleared 510(K)
- K092621PASCAL STREAMLINE PHOTOCOAGULATOR2Cleared 510(K)
- K091534LIGHTLAS MODEL 5322Cleared 510(K)
- K090774LIGHTLAS SELECTOR2Cleared 510(K)
- K091581SUPRA 577.Y LASER2Cleared 510(K)
- K081946SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR2Cleared 510(K)
- K081774SOLX 790 TITANIUM SAPPHIRE LASER2Cleared 510(K)
- K081565INTEGRE PRO, MODEL L2RY2Cleared 510(K)
- K080423INTEGRE, MODEL LP5812Cleared 510(K)
- K072823MERILAS 532A2Cleared 510(K)
- K062624NEXT GENERATION LASER2Cleared 510(K)
- K063297LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR2Cleared 510(K)
- K070776SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR2Cleared 510(K)
- K062074IRIDEX WIRELESS FOOTSWITCH2Cleared 510(K)
- K061024PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.602Cleared 510(K)
- K051944FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES2Cleared 510(K)
- K05080720G SMA LASER FIBER, MODEL LF1002Cleared 510(K)
- K050541OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY2Cleared 510(K)
- K043613Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II2Cleared 510(K)
- K043236FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA2Cleared 510(K)
- K041598LASEREX, MODEL LP45322Cleared 510(K)
- K040209IRIS MEDICAL IQ 810 PHOTOCOAGULATOR2Cleared 510(K)
- K033941MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK2Cleared 510(K)
- K031665IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS2Cleared 510(K)
- K031023PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.102Cleared 510(K)
- K023094IRIDIS OPHTHALMIC PHOTOCOAGULATOR2Cleared 510(K)
- K021538LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR2Cleared 510(K)
- P990078HYPERION LTK SYSTEM2PMA Approval
- K020374OCULIGHT SL/SLX2Cleared 510(K)
- K013760DC-3300 LASER DIODE PHOTOCOAGULATOR2Cleared 510(K)
- K010372LIGHTLAS 532 PHOTOCOAGULATOR2Cleared 510(K)
- P990078SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)2PMA Approval
- P990078HYPERION LTK SYSTEM2PMA Approval
- K001772LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA2Cleared 510(K)
- K990665BQ/BM INTEGRATED LASER DELIVERY SYSTEM2Cleared 510(K)
- K990075LPULSA SYL-9000 OPHTHALMIC YAG LASER2Cleared 510(K)
- K981196MEDITEC LINK2Cleared 510(K)
- K973193LUXSCOPE2Cleared 510(K)
- K973220RODENSTOCK LASER SLITLAMP2Cleared 510(K)
- K972514LASEREX LP1532 PHOTOCOAGULATOR2Cleared 510(K)
- K971950INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER2Cleared 510(K)
- K964751CERALAS DIODE LASER SYSTEM (CERALAS D2)2Cleared 510(K)
- K960971OCULIGHT GL2Cleared 510(K)
- K960522DIOPEXY PROBE2Cleared 510(K)
- K951079NIDEK MODEL GYC-1500 AND GYC-20002Cleared 510(K)
- K952894VISULINK 900 ARGON2Cleared 510(K)
- K942180KEELER MULTILASE 30002Cleared 510(K)
- K935747MEGABEAM ENDOCULAR PROBE2Cleared 510(K)
- K931784HGM ILLUMINATING IMAGING ENDOCULAR PROBE2Cleared 510(K)
- K932836NIDEK MODEL AC-23002Cleared 510(K)
- K932296JR -- OPHTHALMIC ARGON LASER2Cleared 510(K)
- K925663HGM ASPIRATING ENDOOCULAR(TM) PROBE2Cleared 510(K)
- K926470LASER AND EMPHASIS SCLEROSTOMY TIP2Cleared 510(K)
- K910532URAM OPHTHALMIC LASER ENDOSCOPE2Cleared 510(K)
- K910805ND:YAG LASER SYSTEMS (VARIOUS MODELS)2Cleared 510(K)
- K904699COMPAC(TM) DIODE LASERS2Cleared 510(K)
- K905453CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND2Cleared 510(K)
- K910612CANDELA DIODE TRABECULOPLASTY LASER DTL2Cleared 510(K)
- K905141CENTAURI2Cleared 510(K)
- K903421TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER2Cleared 510(K)
- K904366CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR2Cleared 510(K)
- K900199LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY2Cleared 510(K)
- K895213MICROLASE BY LASER TRABECULOPLASTY2Cleared 510(K)
- K895196MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR2Cleared 510(K)
- K894835LASERMED* GOGGLES AND SPECTACLES2Cleared 510(K)
- K894273NIDEK MODEL AKC-80002Cleared 510(K)
- K893630CANDELA UPC LASER PHOTOCOAGULATOR2Cleared 510(K)
- K893709COHERENT MARIE ARGON PHOTOCOAGULATOR2Cleared 510(K)
- K890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM2Cleared 510(K)
- K890086MICROLASE 8 0 0 (OPHTHALMIC LASER)2Cleared 510(K)
- K885164LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM2Cleared 510(K)
- K882908SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.2Cleared 510(K)
- K883213NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)2Cleared 510(K)
- K881494FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER2Cleared 510(K)
- K882372RESUBMITTED DIODE LASER COAGULATOR2Cleared 510(K)
- K881134SLT CONTACT LASER SYSTEM OCULOPLASTICS2Cleared 510(K)
- K875000PRISMA DISPOSABLE ENDO-OCULAR PROBE2Cleared 510(K)
- K874609ZEISS VISULAS ARGON LASER2Cleared 510(K)
- K873460OPHTHALAS DYE OPHTHALMIC LASER2Cleared 510(K)
- K872846NIDEK ADC-8000 LASER SYSTEM2Cleared 510(K)
- K870839MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC2Cleared 510(K)
- K864063ORION 3001, LASER PHOTOCOAGULATOR2Cleared 510(K)
- K863246MIRALITE2Cleared 510(K)
- K863591ENDOPHOTOCOAGULATION PROBE2Cleared 510(K)
- K862568LDS - LASER DELIVERY SYSTEM2Cleared 510(K)
- K862987MODEL 1000 OPHTHALMIC LASER SYSTEM2Cleared 510(K)
- K860358FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)2Cleared 510(K)
- K854949MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS2Cleared 510(K)
- K854288OPHALMIC LASER PHOTOCOAGULATOR2Cleared 510(K)
- K853890OPHTHALMIC LASER PHOTOCOAGULATOR2Cleared 510(K)
- K852529HESSBURG GLIDE UNTRAOCULAR LENS GUIDES2Cleared 510(K)
- K852234MDS 83 OPHTHALMIC DYE LASER SYSTEM2Cleared 510(K)
- K852464HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.2Cleared 510(K)
- K844357SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR2Cleared 510(K)
- K850572HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K2Cleared 510(K)
- K844668MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE2Cleared 510(K)
- K844358SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP2Cleared 510(K)
- K843965ARGON LASER PHOTOCOAGULATOR SYS2Cleared 510(K)
- K842250AMER. MEDICAL OPTICS ARGON/KRYPTON LASE2Cleared 510(K)
- K842251AMERI. MEDICAL OPTICS ARGON LASER PHOTO2Cleared 510(K)
- K842412MODEL 4000 MD-YAG LASER FOR MALIGNANT2Cleared 510(K)
- K841855AMER. MED. OPTICS ARGON LASER PHOTO2Cleared 510(K)
- K841856AMER. MED. OPTICS ARGON/KRYPTON LASER2Cleared 510(K)
- K840590FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE2Cleared 510(K)
- K840145MONITOR CO2 LASER SURGICAL SYSTEM2Cleared 510(K)
- K834610LASER LENS-VARIOUS MODELS2Cleared 510(K)
- K840854MEDICAL LASER ENDOCOAGULATOR 5K2Cleared 510(K)
- K834305ARGON/KRYPTON ION LASER PHOTOCOAGULA2Cleared 510(K)
- K834060RELIANCE OPHTHALMIC SLIT LAMP R-0832Cleared 510(K)
- K833532OCULASE 514 OPHTHALMIC ARGON LASER2Cleared 510(K)
- K833533LASER PHOTOCOAGULATOR 1520-A & K2Cleared 510(K)
- K832316OPHTHALMIC ARGON LASER #700A2Cleared 510(K)
- K832089MODEL 150K LASER COAGULATOR2Cleared 510(K)
- K833232LASER PROTECTIVE EYESHIELD2Cleared 510(K)
- K833274DERMATOLOGY HANDPIECE-OPHTH LASER2Cleared 510(K)
- K813492BRITT KRYPTON LASERS 150K & 152K2Cleared 510(K)
- K812219MODEL 900S INTRAOCULAR PROBE2Cleared 510(K)
- K801336MODEL 900K PHOTOCOAGULATOR2Cleared 510(K)
- K791659MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL2Cleared 510(K)
- K782106COAGULATOR, MODEL 40 AARGON2Cleared 510(K)
- K781965LASER COAGULATOR, MODEL 41AK2Cleared 510(K)
- K782065LASER, PHOTOCOAGULATION2Cleared 510(K)
- HQOUnit, Cautery, Thermal, Ac-Powered2Product Code
- HQPUnit, Cautery, Thermal, Battery-Powered2Product Code
- HQQApparatus, Cautery, Radiofrequency, Battery-Powered2Product Code
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered2Product Code
- HQSBurr, Corneal, Ac-Powered1Product Code
- HRFEngine, Trephine, Accessories, Battery-Powered1Product Code
- HRGEngine, Trephine, Accessories, Ac-Powered1Product Code
- HRHTrephine, Manual, Ophthalmic1Product Code
- HRJTable, Instrument, Powered, Ophthalmic1Product Code
- HRKTable, Instrument, Manual, Ophthalmic1Product Code
- HRNUnit, Cryophthalmic, Ac-Powered2Product Code
- HROUnit, Electrolysis, Ac-Powered, Ophthalmic2Product Code
- HRPPen, Marking, Surgical1Product Code
- KYBLens, Guide, Intraocular1Product Code
- KYGDevice, Irrigation, Ocular Surgery1Product Code
- LCCApplicator, Ocular Pressure2Product Code
- LPOGases Used Within Eye To Place Pressure On Detached Retina3Product Code
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser2Product Code
- LWLFluid, Intraocular3Product Code
- LXPPlug, Scleral2Product Code
- LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla2Product Code
- LZPAid, Surgical, Viscoelastic3Product Code
- MLZVitrectomy, Instrument Cutter2Product Code
- MMCDilator, Expansive Iris (Accessory)2Product Code
- MOECollagen Corneal Shield1Product Code
- MSRTubing, Replacement, Phacofragmentation Unit2Product Code
- MSSFolders And Injectors, Intraocular Lens (Iol)1Product Code
- MUSFluidic, Phacoemulsification/Phacofragmentation2Product Code
- MXOLaser, System, Phacolysis2Product Code
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal1Product Code
- MYDKeratome, Water Jet1Product Code
- NCEInjector, Capsular Tension Ring1Product Code
- NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered2Product Code
- NGYCannula, Trocar, Ophthalmic1Product Code
- NKXNeedle, Phacoemulsification, Reprocessed2Product Code
- NKYBlade, Keratome, Reprocessed1Product Code
- NLAKnife, Ophthalmic, Reprocessed1Product Code
- NVBIntraocular, Pressure Measuring Device3Product Code
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal1Product Code
- OHXBurr, Corneal, Ac-Powered, Rust Ring Removal1Product Code
- OJKEye Tray2Product Code
- OOEOphthalmic Femtosecond Laser2Product Code
- OTZGraft Insertion Instrument For Endothelial Keratoplasty1Product Code
- PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered2Product Code
- PZGSurgical Eye Tray1Product Code
- QDVIol Tray1Product Code
- QDWPhaco Kit2Product Code
- QDYVitrectomy Kit2Product Code
- QGJCorneal Inlay Inserter Handle1Product Code
- QQQGuide And Positioner, Ophthalmic Drug Delivery Device1Product Code
- PYUSponge, Eyelid Cleaning, Powered1Product Code
- QUQKnife, Intraocular Pressure Lowering2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
R:GEN Laser System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K153769
- 510(k) Type
- Traditional
- Applicant
- Lutronic Corporation
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/5/2016
- Days to Decision
- 280 days
- Submission Type
- Summary