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
- 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
- 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
- K2113613N Contact Lenses Adjunct Cleaner2Cleared 510(K)
- K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System2Cleared 510(K)
- K083757BPZ02 MULTIPURPOSE SOLUTION2Cleared 510(K)
- K021699AUTOLENS CLEANING AND DISINFECTING UNIT2Cleared 510(K)
- K022687AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION2Cleared 510(K)
- K020802RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION2Cleared 510(K)
- K994021CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION2Cleared 510(K)
- K991965PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES2Cleared 510(K)
- K982115LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY2Cleared 510(K)
- K974724SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT2Cleared 510(K)
- P960024UNIZYME(TM) ENZYMATIC CLEANER2PMA Approval
- K964222ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING2Cleared 510(K)
- K962112NEW COMFORT CONTACT LENS CARE ACCESSORY2Cleared 510(K)
- K950940OPTI PADS2Cleared 510(K)
- K923816CONTACT LENS CLEANING ACCESSORY2Cleared 510(K)
- K921615LENSONIC(TM) CONTACT LENS CARE ACCESSORY2Cleared 510(K)
- K921882THE CLEANER ACCESSORY2Cleared 510(K)
- K902920TURBOTRON 20/202Cleared 510(K)
- K904824EASY EYES TM CONTACT LENS CLEANING MACHINE2Cleared 510(K)
- K902306THE VISONIC DOME(TM)2Cleared 510(K)
- K892372SPIN-CLEAN CLEANING UNIT2Cleared 510(K)
- K884414CLENSATRON AUTOMATIC CONTACT LENS CLEANER2Cleared 510(K)
- K881739LENZ CLENZER2Cleared 510(K)
- 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
UNIZYME(TM) ENZYMATIC CLEANER
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- CIBA VISION CORPORATION
- Trade Name
- UNIZYME(TM) ENZYMATIC CLEANER
- Generic Name
- Accessories, solution, ultrasonic cleaners for lenses
- Decision Date
- 7/3/1997
- Days to Decision
- 79 days
- Decision Code
- APPR
- FDA Decision
- Approval