FDA 510(k) Applications for Medical Device Product Code "HQG"
(Lens, Spectacle, Non-Custom (Prescription))

FDA 510(k) Number Applicant Device Name Decision Date
K791721 AMERICAN OPTICAL CORP. "ULTRAVUE" BLENDED BIFOCAL LENS 10/23/1979
K761163 AMERICAN OPTICAL CORP. AD7 PLASTIC MULTIFOCAL EYEGLASS LENS 12/16/1976
K790251 AMERICAN OPTICAL CORP. FUL-VUE ASPHERIC CATARACT LENS 02/26/1979
K812051 AMERICAN OPTICAL CORP. PHOTOLITE AOLITE TINTOMATIC LENS 09/08/1981
K853110 ANCIE LABORATORIES SPECTACLE PRESCRIPTION LENSES 08/09/1985
K861960 ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. ZIMLITE LENS 06/09/1986
K852403 AURA LENS PRODUCTS AURALITE II 08/20/1985
K872506 AURA LENS PRODUCTS MELANITE I 07/27/1987
K882308 AUTOMATED LENS SYSTEM CR-39 PLASTIC LENSES FOR EYEGLASSES 07/22/1988
K844778 B & M SPORTING GOODS, INC. SUNGLASSES 01/04/1985
K811554 BARNES-HIND, INC. BARNES-HIND SPECTACLE LENS CLEANER 07/02/1981
K791901 BARNES-HIND, INC. BARNES-HIND WETTING & SOAKING SOLUTION 11/16/1979
K881225 BETA OPTICAL CO, INC. OPHTHALMIC SPECTACLE LENS BLANKS 04/19/1988
K772221 BORANI INTL. LENS, HARD RESIN 01/30/1978
K844321 BUCHMANN OPTICAL INDUSTRIES CUSTOM LITE 11/27/1984
K841248 CHINA TOY & NOVELTY CO., LTD. SUNGLASSES 07/27/1984
K802651 CHIRON VISION CORP. POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) 12/17/1980
K812441 COBURN OPTICAL IND., INC. DI-CROWN 10/06/1981
K821398 CORNING MEDICAL & SCIENTIFIC CORNING CPF 550 LENS 06/25/1982
K861162 EFOP LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) 06/09/1986
K875063 EPSON EL PASO, INC. SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. 02/22/1988
K851163 FULL SEE GLASSES IND. CO., LTD. SUNGLASES 05/30/1985
K772024 GENTEX CORPORATION RX LENS SERIES 11/09/1977
K800521 GENTEX CORPORATION THE LENS OR OMMI-GARD 03/12/1980
K861759 H. GIRARD S.A. GIRARD SUNGLASSES (NON-PRESCRIPTION) 06/09/1986
K842189 HANMY OPTICAL INDUSTRIAL CO. MULTIPLE LENS, SPECTACLES CUSTOM 12/11/1984
K935919 JA-RU, INC. SUNGLASSES 02/16/1994
K874681 KLOCKNER CONTRACT PACKAGING, INC. SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES 02/05/1988
K871961 KOREA ASAHI OPTICAL CO., LTD. MULTIPLE SPECTACLE LENS 06/03/1987
K770955 M.R.M. OPTICS, INC. MIRACLELENS 06/17/1977
K860794 MHCI CORP. WRAPPERS, SUNGLASSES 04/21/1986
K865103 NEO OPTICS, INC. KROM-X LENS SYSTEM 01/20/1987
K882814 NEOLENS, INC. NEOLENS PRESCRIPTION SPECTACLE LENS 07/29/1988
K900091 ONUFRYK LOW VISION ENT. MODIFIED OPHTHALMIC "OPIR" ONUFRYK IMAGE DEFLECTOR 04/04/1990
K851410 OPTICAL MOULDING SYSTEMS O.M.S. UV-COLOURS 08/27/1985
K920795 OPTICAL RADIATION CORP. 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX 07/13/1992
K854218 OPTICAL SYSTEMS INTL., INC. THE ULTRA-MATE LENS 11/12/1985
K850905 ORPLEX CORP. CR-39 TYPE RESIN 03/20/1985
K813130 PANLIN CORP. SUNGLASSES 03/04/1982
K823825 PATTON, BOGGS & BLOW NOSITE UV INTERIM SPECTACLES 02/24/1983
K842187 PAVUNA LTD. MULTIPLE LENS, SPECTACLES, CUSTOM 12/11/1984
K790215 POLYCORE OPTICAL PTE LTD. LENS, POLYCORE 02/26/1979
K861021 PRIVATE EYES SUNGLASS CORP. GOTTEX SUNGLASSES 06/17/1986
K802749 ROBINSON-HOUCHIN, INC. BLENDED BIFOCAL 12/17/1980
K860955 ROSEBURG SA SPECTACLES LENS 03/31/1986
K884360 SEIKO CORP. SEIKO P-6 PROGRESSIVE SPECTACLE LENSES 11/15/1988
K873245 SEIKO OPTICAL PRODUCTS OF AMERICA, INC. AR DIACOAT SINGLE VISION LENSES 10/05/1987
K861684 SEIKO OPTICAL PRODUCTS OF AMERICA, INC. SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) 06/09/1986
K781927 SPECTRA-SHIELD, INC. HUMAN II LENS 12/20/1978
K833259 SUN HOUSE PRODUCTS CO. MULTIPLE 04/02/1984
K862578 TECHNA VISION TECHNA VISION CASTING RESIN 07/23/1986
K772124 TECHSIGHT CORP. LENSES, EYEGLASS, SAFETY 11/16/1977
K772044 TECHSIGHT CORP. TECHSIGHT LENSES WITH ZUMA COATING 11/09/1977
K843096 TITMUS OPTICAL, INC. CRISTY/COTE 11/21/1984
K863367 VISION-SCIENCES, INC. FORMALENS 2000 09/26/1986
K822573 ZEISS SUNGLASS LENSES 10/22/1982


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