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- 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
- 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
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- UnknownReview Panel
iTEAR Neurostimulator
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN190026
- 510(k) Type
- Direct
- Applicant
- Olympic Ophthalmics, Inc.
- Country
- United States
- FDA Decision
- Deleted
- Decision Date
- 5/1/2020
- Days to Decision
- 352 days