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- MiscellaneousMiscellaneous
- OGOIntraocular Pressure Lowering Implant3Product Code
- QQUDigital Therapy Device For Amblyopia2Product Code
- HPXLens, Contact (Polymethylmethacrylate)UProduct Code
- LOGCatheter, Balloon For Retinal Reattachment3Product Code
- LOHSystem, Identification, Contact Lens3Product Code
- LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary3Product Code
- LQBMedical Computers And Software For Ophthalmic Use3Product Code
- LQEImplant, Corneal, Refractive3Product Code
- LXQCup, EyeUProduct Code
- LYXMedia, Corneal StorageUProduct Code
- LZQTissue Adhesive For Ophthalmic Use3Product Code
- LZRUltrasound, Cyclodestructive3Product Code
- LZSExcimer Laser System3Product Code
- LZUPlug, PunctumUProduct Code
- MRJRing, Endocapsular3Product Code
- MSISolution, Cleaning / Lubricating, Artificial Eye3Product Code
- MTALens, Intraocular, Phakic3Product Code
- MURGraft, Sclera, Reinforcement3Product Code
- MWDElectrosurgical, Radio Frequency, Refractive Correction3Product Code
- NBFProsthesis, RetinalFProduct Code
- NCJTelescope, Implantable, Miniature3Product Code
- ODKRefractive Corneal ImplantFProduct Code
- OKSLacrimal Stents And Intubation SetsUProduct Code
- OTLFemtosecond Laser System For Refractive Correction3Product Code
- OXWStimulator, Electrical, Transcutaneous, For Diabetic RetinopathyNProduct Code
- PFZOphthalmic Sealant3Product Code
- QBTArtificial Iris3Product Code
- QITDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia3Product Code
- QCWCorneal Storage Media With Preservatives Including Anti-Fungal2Product Code
- SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device2Product Code
- QQJApplicator, Negative Pressure, External, Ocular2Product Code
- SDELight Based Device For Dry Age-Related Macular Degeneration2Product Code
- QURPrescription Spectacle Lenses To Reduce The Progression Of Myopia2Product Code
- Submissions with No Product CodeMiscellaneous
- K871326DROP MATECleared 510(K)
- K870905SURE DROPCleared 510(K)
- K863662OPHTHALMIC SURGICAL DRAPECleared 510(K)
- K863666THE SAVER KITCleared 510(K)
- K861415CANON AUTO REF KERATOMETER RK-1Cleared 510(K)
- K861163XTAL X-800 SHADOWGRAPHCleared 510(K)
- K861333ULTRA-VIOLET GOGGLETSCleared 510(K)
- K861028SUPERLITE PENLIGHTCleared 510(K)
- K860928EYEMETERCleared 510(K)
- K854872VFI/VFE SYSTEM IICleared 510(K)
- P080010TECNIS 3-Poece MultifocalOK30PMA Approval
- P080010Tecnis 3-piece MultifocalOK30PMA Approval
- P810031Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual PackAPPRPMA Approval
- P810031HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVIAPPRPMA Approval
- P060011RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSESAPPRPMA Approval
- P060011RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSESOK30PMA Approval
- P980040SENSAR SOFT ACRYLIC INTRAOCULAR LENSESOK30PMA Approval
- P980040TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOLOK30PMA Approval
- P060011RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSESOK30PMA Approval
- P980040TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22OK30PMA Approval
- P980040TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC POK30PMA Approval
- P980040TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZBM00, SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-POK30PMA Approval
- P980040SENSAR 1-PIECE LENS MODEL AAB00OK30PMA Approval
- P980040TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOAOK30PMA Approval
- P980040TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-POK30PMA Approval
- P980040TECNIS OPTIBLUE 1-PIECE IOLAPPRPMA Approval
- P980040TECNIS 1-PIECE IOL TEDNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOLOK30PMA Approval
- P980040SENSAR ACRYLIC IOL, TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE IOL, TECNIS MULTIFOCAL 1-PIECE IOLOK30PMA Approval
- P990080SILICONE POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911AAPPRPMA Approval
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- K854140MODIFIED MYDRIATIC SPECTACLECleared 510(K)
- K854169PUPILSCANCleared 510(K)
- K854256KEELER AMOILS SURGICAL ASTIGOMETERCleared 510(K)
- K853631POLY-SLEEVECleared 510(K)
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- K853199INTEGRITY EYE DROP GUIDE(MODIFICATION)Cleared 510(K)
- K842814PERMALID LINER PAKCleared 510(K)
- K842781PERMALID PAKCleared 510(K)
- K852187SITE INFUSION CONTACT LENS W/ILLUMINATORCleared 510(K)
- K852229STERILE EYE PACKS OR TRAYSCleared 510(K)
- K851908INTEGRITY EYE DROP GUIDECleared 510(K)
- K850649ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANTCleared 510(K)
- K851008ELECTRIC LIFT TABLE-OPHTHALMICCleared 510(K)
- K850962OPHTHALMIC DROPPER BOTTLESCleared 510(K)
- K841430LASERSPECCleared 510(K)
- K841896EZ EYE DROP AIDCleared 510(K)
- K843345AGL400 ARGON LASER SYSTEM-KRL500 KRYPTONCleared 510(K)
- K834539AXIPAC IICleared 510(K)
- K842459SITE GILLS STYLE I/A HANDPIECECleared 510(K)
- K832327SILA CLEAN 20/20Cleared 510(K)
- K841273ACCOMMOTRAC VISION TRAINERCleared 510(K)
- K841652OCULAR PRESSURE APPLICATORCleared 510(K)
- K841316FLATPACK CARRYING CASECleared 510(K)
- K840430SUN-LITE WHITE SLITCleared 510(K)
- K840427SUN-LITE BLUE SPOTCleared 510(K)
- K840428SUN-LITE PEN LIGHTCleared 510(K)
- K833024OFTALMOGRAFCleared 510(K)
- K840493SURG A STAT FINE TIP 5Cleared 510(K)
- K832589ELMED WMC 10 AND BC 50 M/MCleared 510(K)
- K840456SUN-LITE 1Cleared 510(K)
- K840429SUN-LITE ONE MILLIMETERCleared 510(K)
- K840982LASER MIRRORCleared 510(K)
- K832938OCUTOME PARATUBING SETCleared 510(K)
- K832477OCULOPRESSORCleared 510(K)
- K832461POLYCORECleared 510(K)
- K832085LENSOMETERCleared 510(K)
- K830737JERMYN OCCLUDERS KITCleared 510(K)
- K822542POLYCORECleared 510(K)
- K822541VISIOPAL 75Cleared 510(K)
- K822429SINGLE VISION POWER LENSCleared 510(K)
- K822431SUNGLASS & SAFETY PLANO LENSCleared 510(K)
- K822430KRYPTOX-ROUND SEGMENT BIFOCALCleared 510(K)
- K822529SPECIAL EYE MIRRORCleared 510(K)
- K822125MODEL 57000 NASO-CONJUNCTIVA ISOL. MASKCleared 510(K)
- K812015GLAUKONCleared 510(K)
- K813483OMS ANTERIOR CHAMBER INFUSION NEEDLECleared 510(K)
- K810400GLYCERINE DEHYDRATION UNITCleared 510(K)
- K811117EYE CARE TRAYCleared 510(K)
- K802881ABSELE* ABSORBABLE BONE SEALANTCleared 510(K)
- K802691OCCUPAK CAT.#200-0538Cleared 510(K)
- K772228ALSITE MAGNIVISIONCleared 510(K)
- K772055PENTAX F.O.-IT OBSERVER SCOPECleared 510(K)
- K770728INTRAOCULAR LENSCleared 510(K)
- K761178ETO METHOD - STERILIZE INTRAOCULAR LENSCleared 510(K)
- N17796BRYREL SYRUPAPWDPMA Approval
- N17397ACEPTOPLAST CONTACT LENSAPWDPMA Approval
- N17622FLOURESCEIN SODIUM OPHTHALMIC STRIPSAPCVPMA Approval
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
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Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Trade Name
- HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
- Generic Name
- AID, SURGICAL, VISCOELASTIC
- Decision Date
- 1/14/1983
- Days to Decision
- 556 days
- Decision Code
- APPR
- FDA Decision
- Approval