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
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- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- 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
- HJFMagnifier, Hand-Held, Low-Vision1Product Code
- HJGSystem, Reading, Television, Closed-Circuit1Product Code
- HJHLoupe, Binocular, Low Power1Product Code
- HJXReader, Prism, Ophthalmic1Product Code
- HJYReader, Bar, Ophthalmic1Product Code
- HJZCrutch, Ptosis1Product Code
- HKBTelescope, Hand-Held, Low-Vision1Product Code
- HKCSpectacle Microscope, Low-Vision1Product Code
- HKKTelescope, Spectacle, Low-Vision1Product Code
- HOISpectacle, Magnifying1Product Code
- HOTAid, Vision Image Intensification1Product Code
- HPEAid, Vision, Optical, Battery-Powered1Product Code
- HPFAid, Vision, Electronic, Ac-Powered1Product Code
- HPGAid, Vision, Electronic, Battery-Powered1Product Code
- HPIAid, Vision, Optical, Ac-Powered1Product Code
- HQDLens, Contact (Other Material) - Daily2Product Code
- HQGLens, Spectacle, Non-Custom (Prescription)1Product Code
- K935919SUNGLASSES1Cleared 510(K)
- K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX1Cleared 510(K)
- K900091MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR1Cleared 510(K)
- K884360SEIKO P-6 PROGRESSIVE SPECTACLE LENSES1Cleared 510(K)
- K882814NEOLENS PRESCRIPTION SPECTACLE LENS1Cleared 510(K)
- K882308CR-39 PLASTIC LENSES FOR EYEGLASSES1Cleared 510(K)
- K881225OPHTHALMIC SPECTACLE LENS BLANKS1Cleared 510(K)
- K875063SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P.1Cleared 510(K)
- K874681SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES1Cleared 510(K)
- K873245AR DIACOAT SINGLE VISION LENSES1Cleared 510(K)
- K872506MELANITE I1Cleared 510(K)
- K871961MULTIPLE SPECTACLE LENS1Cleared 510(K)
- K865103KROM-X LENS SYSTEM1Cleared 510(K)
- K863367FORMALENS 20001Cleared 510(K)
- K862578TECHNA VISION CASTING RESIN1Cleared 510(K)
- K861021GOTTEX SUNGLASSES1Cleared 510(K)
- K861960ZIMLITE LENS1Cleared 510(K)
- K861759GIRARD SUNGLASSES (NON-PRESCRIPTION)1Cleared 510(K)
- K861684SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)1Cleared 510(K)
- K861162LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)1Cleared 510(K)
- K860794WRAPPERS, SUNGLASSES1Cleared 510(K)
- K860955SPECTACLES LENS1Cleared 510(K)
- K854218THE ULTRA-MATE LENS1Cleared 510(K)
- K851410O.M.S. UV-COLOURS1Cleared 510(K)
- K852403AURALITE II1Cleared 510(K)
- K853110SPECTACLE PRESCRIPTION LENSES1Cleared 510(K)
- K851163SUNGLASES1Cleared 510(K)
- K850905CR-39 TYPE RESIN1Cleared 510(K)
- K844778SUNGLASSES1Cleared 510(K)
- K842189MULTIPLE LENS, SPECTACLES CUSTOM1Cleared 510(K)
- K842187MULTIPLE LENS, SPECTACLES, CUSTOM1Cleared 510(K)
- K844321CUSTOM LITE1Cleared 510(K)
- K843096CRISTY/COTE1Cleared 510(K)
- K841248SUNGLASSES1Cleared 510(K)
- K833259MULTIPLE1Cleared 510(K)
- K823825NOSITE UV INTERIM SPECTACLES1Cleared 510(K)
- K822573SUNGLASS LENSES1Cleared 510(K)
- K821398CORNING CPF 550 LENS1Cleared 510(K)
- K813130SUNGLASSES1Cleared 510(K)
- K812441DI-CROWN1Cleared 510(K)
- K812051PHOTOLITE AOLITE TINTOMATIC LENS1Cleared 510(K)
- K811554BARNES-HIND SPECTACLE LENS CLEANER1Cleared 510(K)
- K802749BLENDED BIFOCAL1Cleared 510(K)
- K802651POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)1Cleared 510(K)
- K800521THE LENS OR OMMI-GARD1Cleared 510(K)
- K791901BARNES-HIND WETTING & SOAKING SOLUTION1Cleared 510(K)
- K791721ULTRAVUE BLENDED BIFOCAL LENS1Cleared 510(K)
- K790251FUL-VUE ASPHERIC CATARACT LENS1Cleared 510(K)
- K790215LENS, POLYCORE1Cleared 510(K)
- K781927HUMAN II LENS1Cleared 510(K)
- K772221LENS, HARD RESIN1Cleared 510(K)
- K772124LENSES, EYEGLASS, SAFETY1Cleared 510(K)
- K772044TECHSIGHT LENSES WITH ZUMA COATING1Cleared 510(K)
- K772024RX LENS SERIES1Cleared 510(K)
- K770955MIRACLELENS1Cleared 510(K)
- K761163AD7 PLASTIC MULTIFOCAL EYEGLASS LENS1Cleared 510(K)
- HQYSunglasses (Non-Prescription Including Photosensitive)1Product Code
- HQZFrame, Spectacle1Product Code
- HRCSterilizer, Soft-Lens, Thermal, Battery-Powered2Product Code
- HRDSterilizer, Soft-Lens, Thermal, Ac-Powered2Product Code
- HRLUnit, Beta, Radiation, Ophthalmic2Product Code
- KYEInserter/Remover Contact Lens1Product Code
- LPLLenses, Soft Contact, Daily Wear2Product Code
- LPMLenses, Soft Contact, Extended Wear3Product Code
- LPNAccessories, Soft Lens Products2Product Code
- LRXCase, Contact Lens2Product Code
- LYLAccessories, Solution, Ultrasonic Cleaners For Lenses2Product Code
- MMLWeights, Eyelid, External2Product Code
- MRCProducts, Contact Lens Care, Rigid Gas Permeable2Product Code
- MUWLens, Contact (Orthokeratology)2Product Code
- MVNLens, Contact, (Disposable)2Product Code
- MWLLens, Contact (Rigid Gas Permeable), Extended Wear3Product Code
- MZDSystem, In-Office Tinting, Contact Lenses2Product Code
- NAILens, Prescription, Color Deficiency1Product Code
- NCBWeights, Eyelid, Implantable2Product Code
- NCZLens, Contact, For Color Vision Deficiency2Product Code
- NICLens, Contact, For Reading Discomfort2Product Code
- NJHLens, Spectacle (Prescription), For Reading Discomfort1Product Code
- NUULens, Contact, Orthokeratology, Overnight3Product Code
- ORZEyelid Thermal Pulsation System2Product Code
- PICOral Electronic Vision Aid2Product Code
- PLXTear Duct Occluder1Product Code
- PQJIntranasal Electrostimulation Device2Product Code
- QBRIntranasal Electrostimulation Device For Dry Eye Symptoms2Product Code
- QIUIntense Pulsed Light Device For Managing Dry Eye2Product Code
- QKVElectromechanical Tear Stimulator2Product Code
- QMMHydrophilic Re-Coating Solution2Product Code
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
THE LENS OR OMMI-GARD
- Page Type
- Cleared 510(K)
- 510(k) Number
- K800521
- 510(k) Type
- Traditional
- Applicant
- GENTEX CORPORATION
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/12/1980
- Days to Decision
- 6 days