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
- K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)2Cleared 510(K)
- K233398Faros Surgical System2Cleared 510(K)
- K233876UNITY VCS (8065000296); UNITY CS (8065000297)2Cleared 510(K)
- K232084Stellaris Elite vision enhancement system2Cleared 510(K)
- K233902Centurion™ Vision System (Active Sentry™) (8065753057)2Cleared 510(K)
- K230858QUATERA 7002Cleared 510(K)
- K214028MICOR Lens Fragmentation System2Cleared 510(K)
- K222236miCOR System Lens Fragmentation System2Cleared 510(K)
- K213467EVA NEXUS Ophthalmic Surgical System2Cleared 510(K)
- K212241QUATERA 7002Cleared 510(K)
- K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control2Cleared 510(K)
- K200207xPORT S Lens Fragmentation System2Cleared 510(K)
- K200584xPORT 304 (miCOR) System Lens Fragmentation System2Cleared 510(K)
- K193376Visalis V500, Visalis S5002Cleared 510(K)
- K192418Phacoemulsification Needle (Tip) and Irrigation Sleeve2Cleared 510(K)
- K191650LEGION System2Cleared 510(K)
- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)2Cleared 510(K)
- K191933COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal2Cleared 510(K)
- K191024xPORT Lens Fragmentation System2Cleared 510(K)
- K170052Stellaris Elite vision enhancement system2Cleared 510(K)
- K161794CENTURION Vision System (Active SentryTM)2Cleared 510(K)
- K162342Stellaris Elite Vision Enhancement System2Cleared 510(K)
- K160236Dual Pump Pack2Cleared 510(K)
- K151636AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control2Cleared 510(K)
- K151783COMPACT INTUITIV Multiple-Use Pack2Cleared 510(K)
- K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)2Cleared 510(K)
- K133562CATARHEX 32Cleared 510(K)
- K133486STELLARIS PC VISION ENHANCEMENT SYSTEM2Cleared 510(K)
- K133115COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK2Cleared 510(K)
- K133242STELLARIS VISION ENHANCEMENT SYSTEM2Cleared 510(K)
- K121555CENTURION VISION SYSTEM2Cleared 510(K)
- K122829LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS2Cleared 510(K)
- K121721LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)2Cleared 510(K)
- K120732LENSSX LASER SYSTEM2Cleared 510(K)
- K120912INFINITI(R) VISION SYSTEM2Cleared 510(K)
- K111446SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM2Cleared 510(K)
- K112425INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE2Cleared 510(K)
- K111882LAMINAR FLOW PHACO TIPS2Cleared 510(K)
- K111697AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM2Cleared 510(K)
- K103023UNIT, PHACOFRAGMENTATION2Cleared 510(K)
- K101285CONSTELLATION VISION SYSTEM2Cleared 510(K)
- K101325STELLARIS PC VISION ENHANCEMENT SYSTEM2Cleared 510(K)
- K093210AQUALASE CAPSULE WASH TIP2Cleared 510(K)
- K091915FLUID ISOLATION DEVICE2Cleared 510(K)
- K091777ALCON ULTRACHOPPER2Cleared 510(K)
- K082845INFINITI VISION SYSTEM WITH OZIL IP2Cleared 510(K)
- K082473BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM2Cleared 510(K)
- K081877ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS2Cleared 510(K)
- K080803VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 5512Cleared 510(K)
- K082132BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK2Cleared 510(K)
- K063583ALCON VISION SYSTEM2Cleared 510(K)
- K073023STERILS SINGLE-USE I/A HANDPIECES2Cleared 510(K)
- K063331BAUSCH & LOMB NGX MICROSURGICAL SYSTEM2Cleared 510(K)
- K060366THE AMO OPHTHALMIC SURGICAL SYSTEM2Cleared 510(K)
- K051186MICROPULSE PHACOEMULSIFICATION SYSTEM2Cleared 510(K)
- K050648SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK2Cleared 510(K)
- K041998PHACO CHOP NEEDLES2Cleared 510(K)
- K033653VENTURI PHACO PACK2Cleared 510(K)
- K030957PERFECT CAPSULE2Cleared 510(K)
- K031404DIGNITY OPHTHALMIC SURGICAL SYSTEM2Cleared 510(K)
- K022833BENJAMIN ENVOY PHACO HANDPIECE2Cleared 510(K)
- K020527HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-20302Cleared 510(K)
- K021566INFINITI2Cleared 510(K)
- K020734SURGE-FREE ASPIRATION ADAPTER2Cleared 510(K)
- K003638MOJAVE CATARACT EXTRACTION SYSTEM2Cleared 510(K)
- K003512LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II2Cleared 510(K)
- K002932PHACOGARD2Cleared 510(K)
- K002031PHACOFRAGMENTATION SYSTEM MEGATRON2Cleared 510(K)
- K002986A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.52Cleared 510(K)
- K002812IRIS RETRACTING PHACOEMULSIFICATION SLEEVE2Cleared 510(K)
- K991852OCUSYSTEM ART ADVANTAGE, MODEL 9952Cleared 510(K)
- K984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM2Cleared 510(K)
- K981989THE WAVE DIGITAL PHACO SYSTEM2Cleared 510(K)
- K981103TURBOSONICS LIMITED REUSE ULTRASONIC TIP2Cleared 510(K)
- K981109QUITETIP2Cleared 510(K)
- K980480SYNTEC VITMAN2Cleared 510(K)
- K980085PHACO COMMANDER2Cleared 510(K)
- K974469MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL2Cleared 510(K)
- K974719PHACOPAK2Cleared 510(K)
- K973749FRAG COMMANDER2Cleared 510(K)
- K972063WHITTINGHAM ULTRACLEAN PHACO HANDPIECE2Cleared 510(K)
- K972252VISTA UNIVERSAL HANDPIECE2Cleared 510(K)
- K972253P3 UNIVERSAL PHACO HANDPIECE2Cleared 510(K)
- K971795AUTOMATED CHAMBER MAINTENANCE MODULE2Cleared 510(K)
- K971750WELCH ALLYN PHACO ILLUMINATOR2Cleared 510(K)
- K971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES2Cleared 510(K)
- K971186AMO DIPLOMAX/OPSYS CONSOLE2Cleared 510(K)
- K971064BAYERS BIMANUAL I/A HANDPIECES2Cleared 510(K)
- K965127DGH MODEL 90002Cleared 510(K)
- K964018PHACOILLUMINATOR - FIBEROPTIC SLEEVE2Cleared 510(K)
- K960287HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM2Cleared 510(K)
- K960811PHACOSCOPE2Cleared 510(K)
- K960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH2Cleared 510(K)
- K962402AMO PRESTIGE DAY PACK (ALLERGAN, INC.)2Cleared 510(K)
- K960003STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION2Cleared 510(K)
- K962131STORZ D4600 AIR EXCHANGE LINE PACK2Cleared 510(K)
- K961874STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK2Cleared 510(K)
- K961831STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK2Cleared 510(K)
- K961820STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK2Cleared 510(K)
- K962430CTM REUSABLE PAK2Cleared 510(K)
- K962431CTM DISPOSABLE PAK2Cleared 510(K)
- K961658MEGATRON OPHTHALMIC SURGICAL SYSTEM2Cleared 510(K)
- K961243OCUSYSTEM ART ADVANTAGE2Cleared 510(K)
- K961310STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)2Cleared 510(K)
- K960414SYNERGIST POWER PACK2Cleared 510(K)
- K955901STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX2Cleared 510(K)
- K955789ALCON SERIES 20000 LEGACY MACKOOL SYSTEM2Cleared 510(K)
- K955245MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM2Cleared 510(K)
- K954746PHACO TIP2Cleared 510(K)
- K953538RM001 REUSABLE2Cleared 510(K)
- K953539DM001 DISPOSABLE PACK2Cleared 510(K)
- K954340STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE2Cleared 510(K)
- K954238SURGIN GENISIS HANDPIECE2Cleared 510(K)
- K954239U.S. IOL PHACO HANDPIECE2Cleared 510(K)
- K954237CIRCUIT TREE PHACO HANDPIECE2Cleared 510(K)
- K954242CIRCUIT TREE PHACOEMULSIFIER2Cleared 510(K)
- K954241SURGIN GENISIS PHACOEMULSIFIER2Cleared 510(K)
- K954240EVOLUTION PHACOMULSIFIER2Cleared 510(K)
- K953959PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES2Cleared 510(K)
- K951463STORZ I/A HANDPIECES2Cleared 510(K)
- K953359TRI-STAR UNIVERSAL I/A PHACO PAK2Cleared 510(K)
- K953447PRECISIONIST THIRTY THOUSAND2Cleared 510(K)
- K944993IOLAB.SITE CD PHACOEMULSIFICATION MODULE2Cleared 510(K)
- K944995IOLAB/SITE PERISTALTIC MODULE2Cleared 510(K)
- K950881PHACO TIP2Cleared 510(K)
- K952468HI-LINE MEDICAL PHACOEMULSIFIER TIP2Cleared 510(K)
- K952331AOI LC-40 PHACOEMULSIFIER2Cleared 510(K)
- K952213ALCON SERIES 20000 LEGACY PHACOEMULSIFIER2Cleared 510(K)
- K953078STORZ DP4101 BASIC I/A PACK2Cleared 510(K)
- K951824STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)2Cleared 510(K)
- K950218OMS SLIMLINE PHACO HANDPIECE2Cleared 510(K)
- K946054DIPLOMAX2Cleared 510(K)
- K951462AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM2Cleared 510(K)
- K952259STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES2Cleared 510(K)
- K950114STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM2Cleared 510(K)
- K950880AOI UNIVERSAL ULTRASONIC HANDPIECE2Cleared 510(K)
- K950798POSTERIOR CAPSULE SHIELD2Cleared 510(K)
- K950800PRO-PAK FOR OMS DIPLOMATE2Cleared 510(K)
- K950600VACUUM SURGE SUPRESSER2Cleared 510(K)
- K946227STORZ PREMIERE(R) MICROSURGICAL SYSTEM2Cleared 510(K)
- K944994IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE2Cleared 510(K)
- K946176STORZ PHACOEMULSIFICATION NEEDLES2Cleared 510(K)
- K945583OCUSYSTEM(ART)2Cleared 510(K)
- K942945CASSETTE SYSTEM FOR STORZ2Cleared 510(K)
- K935926STORZ PHACO AND FRAG HANDPIECES2Cleared 510(K)
- K943672PHACO NEEDLES AND TIPS2Cleared 510(K)
- K943379PHACO TIPS FOR PHACO FRAGMENTATION MACHINES2Cleared 510(K)
- K940083STANDARD PHACO TIP 15, 30, 45, 602Cleared 510(K)
- K940088MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE2Cleared 510(K)
- K943102HIGH PERFORMANCE TIPS2Cleared 510(K)
- K94251710-K CASSETTE2Cleared 510(K)
- K942518CASSETTE SYSTEM FOR SITE2Cleared 510(K)
- K94251610-0 CASSETTE2Cleared 510(K)
- K942515PHACO KIT2Cleared 510(K)
- K940084MODEL 2000 OPHTHALMIC SURGICAL SYSTEM2Cleared 510(K)
- K923630PHACO NEEDLES 1000-R & 1000-O NEEDLES2Cleared 510(K)
- K935223OPHTHALMIC SURGICAL SYSTEM2Cleared 510(K)
- K931354P4000 PHACOEMULSIFIER2Cleared 510(K)
- K931358AORP4000 REUSABLE PAK2Cleared 510(K)
- K925828MODIFIED SITE TXR SYSTEMS2Cleared 510(K)
- K933627PHACOFRAGMENTOR TIP2Cleared 510(K)
- K931357AOD4000 DISPOSABLE PAK2Cleared 510(K)
- K933503PRO-PHACO HANDPIECE2Cleared 510(K)
- K926381OCUSYSTEM IIE2Cleared 510(K)
- K931866SITE'S CD II PHACOEMULSIFICATION HANDPIECE2Cleared 510(K)
- K926512STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE2Cleared 510(K)
- K925631PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE2Cleared 510(K)
- K924260NIDEK CV-120002Cleared 510(K)
- K923725OPHTHALMIC PHARCO NEEDLE2Cleared 510(K)
- K925254AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-382Cleared 510(K)
- K924235AMO ELITE2Cleared 510(K)
- K924033ALTEX MODEL UST-3000E2Cleared 510(K)
- K922595MODIFIED SITE MACROBORE PHACO NEEDLE2Cleared 510(K)
- K921607IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE2Cleared 510(K)
- K912904MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM2Cleared 510(K)
- K921135IOLAB POWER I.V. POLE2Cleared 510(K)
- K915457PHACO 20/20 SYSTEM I2Cleared 510(K)
- K915456PHACO 3000 LINEAR2Cleared 510(K)
- K915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE2Cleared 510(K)
- K914229PHACO TIP2Cleared 510(K)
- K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE2Cleared 510(K)
- K914172KPE 230 AM2Cleared 510(K)
- K913530LOOK VISCODISSECTOR2Cleared 510(K)
- K912739SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE2Cleared 510(K)
- K911808GEMINI OPHTHALMIC SURGERY SYSTEM2Cleared 510(K)
- K904612I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)2Cleared 510(K)
- K904183SITE PHACOEMULSIFICATION HANDPIECE2Cleared 510(K)
- K904151SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE2Cleared 510(K)
- K902876PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.2Cleared 510(K)
- K902798AUTOMATED HYDROSONICS(TM)2Cleared 510(K)
- K900493THE PRECISIONIST2Cleared 510(K)
- K902150PIEZO HANDPIECE2Cleared 510(K)
- K901686NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-80002Cleared 510(K)
- K894512PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS2Cleared 510(K)
- K894511MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT2Cleared 510(K)
- K892852SITE PHACO PLUS INFUSION SLEEVE2Cleared 510(K)
- K891161VITRECTOMY PACK #J1202Cleared 510(K)
- K890825JUMPER PACK #2032Cleared 510(K)
- K892911SITE PERISTALTIC CASSETTE2Cleared 510(K)
- K890635CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.2Cleared 510(K)
- K890080PHACOEMULSIFIER MODEL 1002Cleared 510(K)
- K884241STAAR PHACO XL SMALL INCISION SYSTEM2Cleared 510(K)
- K883097GV3000 PHACOEMULSIFIER/FRAGMENTER2Cleared 510(K)
- K883199MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM2Cleared 510(K)
- K883099SITE MACROBORE PHACO NEEDLE2Cleared 510(K)
- K882103SITE ULTRASONIC I/A PHACO NEEDLE2Cleared 510(K)
- K881635NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM2Cleared 510(K)
- K880062C-MATE #CMU 10012Cleared 510(K)
- K874334SOLOS SINGLE USE TITANIUM TIP2Cleared 510(K)
- K872611SOLOS EYESITE CAP SLEEVE2Cleared 510(K)
- K871473PART #860065 IA PAK & PART #860060 IA PAK2Cleared 510(K)
- K872362FRIGITRONICS ACC-1000 CAPSULE CUTTER2Cleared 510(K)
- K871854IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS2Cleared 510(K)
- K871485SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE2Cleared 510(K)
- K871649CLASSIC 70 LENS2Cleared 510(K)
- K870671PHACOTRON DAY PAK2Cleared 510(K)
- K870806NON-STERILE, EXTRA PLUS PAK CAT. #USPK 21002Cleared 510(K)
- K864726I/A/KPE TIP2Cleared 510(K)
- K864301SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)2Cleared 510(K)
- K864056GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT2Cleared 510(K)
- K863444GRIESHABER GLOBAL CONTROL TUBING SET2Cleared 510(K)
- K863729OPHTHALMIC FITLER MICRO CAPSULE2Cleared 510(K)
- K863209US PLUS-PAK(R) SURGICAL SYSTEM2Cleared 510(K)
- K862777MODEL A-8000 ULTRASONIC HANDPIECE CORD2Cleared 510(K)
- K862021PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM2Cleared 510(K)
- K862064ENTRAVISION EP-500 I/A ECCO PACK2Cleared 510(K)
- K862063ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE2Cleared 510(K)
- K860957DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.2Cleared 510(K)
- K860956KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.2Cleared 510(K)
- K861060SITE PHACO DISPOSABLE CASSETTE2Cleared 510(K)
- K860989SITE DISPOSABLE CASSETTE2Cleared 510(K)
- K860770AM-100 I/A AMPAC2Cleared 510(K)
- K854375COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR2Cleared 510(K)
- K854225ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS2Cleared 510(K)
- K854116PHACO PACKS, 1A PACKS & PACK COMPONENTS2Cleared 510(K)
- K844373O.M.S. ULTRA-PHACO2Cleared 510(K)
- K853883TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR2Cleared 510(K)
- K853189CREAT BRAND I/A PACK CREAT BRAND PHACO PACK2Cleared 510(K)
- K853070COOPER VISION SYSTEM VI U/S MODULE2Cleared 510(K)
- K852208PHACO-BAC STOP FILTER KIT2Cleared 510(K)
- K851674PHAKOSYSTEMS MODEL CES 41002Cleared 510(K)
- K851211PHACO PAK I2Cleared 510(K)
- K851212UNITED SONICS PACO SYSTEM MODEL 30002Cleared 510(K)
- K851298MID LABS MVSXI2Cleared 510(K)
- K851210UNITED SONICS PHACO MODULE, DF-352Cleared 510(K)
- K851209CILCO/UNITED SONICS PHACE PF-90002Cleared 510(K)
- K843276IOCARE CONVERTER KIT2Cleared 510(K)
- K850532ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK2Cleared 510(K)
- K850275KCP PAK #2 CONVENIENCE PACK MODIFICATION2Cleared 510(K)
- K850149KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA2Cleared 510(K)
- K850148KCP PAK CONVENIENCE PACK2Cleared 510(K)
- K851009INFUSION SLEEVE - OPHTHALMIC2Cleared 510(K)
- K850578PHACOEMULSIFICATION TIP2Cleared 510(K)
- K850900PHACO-BAC STOP KIT2Cleared 510(K)
- K850899I/A BAC STOP KIT2Cleared 510(K)
- K843487VISITEC OPHTHALMIC FLUID DISTRIB- SET2Cleared 510(K)
- K843319CILCO I/A SURGICAL PACK2Cleared 510(K)
- K844666SITE ULTRASONIC EMULSIFICATION MODULE OP2Cleared 510(K)
- K844150MEDICAL OPTICS PHACOEMULSIFICATION KIT2Cleared 510(K)
- K842945COOPERVISION SYSTEM VI2Cleared 510(K)
- K843386MENDEZ U/S CYSTOTOME2Cleared 510(K)
- K843278IOCARE ULTRASONIC TITANIUM TIPS2Cleared 510(K)
- K843277IOCARE PHACOEMULSIFICATION PACK2Cleared 510(K)
- K843275IOCARE IRRIGATION/ASPIRATION PACK2Cleared 510(K)
- K842979CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA2Cleared 510(K)
- K840181CATAREX/ULTRASONICS KIT2Cleared 510(K)
- K840063CATAREX VITRECUTTER I/A DISPOS. CUT2Cleared 510(K)
- K842458SITE SIMCOE STYLE I/A HANDPIECE2Cleared 510(K)
- K840495MANUAL IRRIGATING/ASPIRATING UNIT2Cleared 510(K)
- K840695PHACOEMULSIFICATION KITS2Cleared 510(K)
- K840965SITE COAXIAL I/A HANDPIECE 30 TIP2Cleared 510(K)
- K834340IOCARE IRRIGATION & ASPIRATION PACK2Cleared 510(K)
- K841072IRRIGATION, ASPIRATION TUBING SETS2Cleared 510(K)
- K834453PHACO FRAGMENTOR GT-12Cleared 510(K)
- K834537MICRO VIT FRAGMENTATION SYSTEM2Cleared 510(K)
- K834543OCUCARE ULTRASOUND TIP & FREEDOM PACK2Cleared 510(K)
- K834261PLASTIC OPTICAL LENS M-1102Cleared 510(K)
- K833465DISPOSABLE FIBER OPTIC ILLUMINATOR2Cleared 510(K)
- K833961I/A PLUS PAK SURGICAL SYSTEM2Cleared 510(K)
- K833962KPE PLUS-PAK SURGICAL SYSTEM2Cleared 510(K)
- K833783DISPOS. I/A & IRRIGATION HANDPIECES2Cleared 510(K)
- K833642PHAKO SYSTEMS VIA 20002Cleared 510(K)
- K833784DISPOSABLE I/A HANDPIECE2Cleared 510(K)
- K833405IRRIGATION ASPIRATION KIT2Cleared 510(K)
- K833800BEECHER 20 GA. PROBE2Cleared 510(K)
- K833064STORZ EXTRA2Cleared 510(K)
- K832529M.S.D. ASPIRATOR2Cleared 510(K)
- K833697EXTRA SENSORY PAK-DISPOS. ACCESS2Cleared 510(K)
- K833617EXTRA PLUS TM2Cleared 510(K)
- K834159PHACOTRON PLUS2Cleared 510(K)
- K834161UNIVERSAL PAC2Cleared 510(K)
- K834158EXTRA SENSORY PLUS2Cleared 510(K)
- K832980VXTRA OCUTOME KIT2Cleared 510(K)
- K832997EPA AUTOMATED INFUSION POLE2Cleared 510(K)
- K832413SIAS IRRIGATION/ASPIRATION SYSTEM2Cleared 510(K)
- K832559OCUCARE FREEDOM PACK2Cleared 510(K)
- K832424ENVISION G31 P.E. PAK2Cleared 510(K)
- K832423ENVISION G21 I/A ENPAK2Cleared 510(K)
- K831701UNIVERSAL PACK2Cleared 510(K)
- K831836EPSILON ULTRASONIC TIP2Cleared 510(K)
- K831172ULTRAKIT2Cleared 510(K)
- K830812ALPHAMEDIX I/A HAND-PIECE, 500-0012Cleared 510(K)
- K830902OCUCARE PACK2Cleared 510(K)
- K823088ASPITRON2Cleared 510(K)
- K830474IV STAND2Cleared 510(K)
- K830385IRRIGATION/ASPIRATION KIT2Cleared 510(K)
- K830379PHAKO KIT2Cleared 510(K)
- K812126ULTRASONIC TIPS2Cleared 510(K)
- K802381LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.2Cleared 510(K)
- K782141LEVIGATOR, KEELER PHOKO2Cleared 510(K)
- K771644FRAGMATOME MODEL 8202Cleared 510(K)
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2Product Code
- HQFLaser, Ophthalmic2Product Code
- 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
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K190875
- 510(k) Type
- Traditional
- Applicant
- D.O.R.C. Dutch Ophthalmic Research Center (International)
- Country
- Netherlands
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/25/2019
- Days to Decision
- 174 days
- Submission Type
- Summary