HQG · Lens, Spectacle, Non-Custom (Prescription)
Ophthalmic · 21 CFR 886.5844 · Class 1
Overview
| Product Code | HQG |
|---|---|
| Device Name | Lens, Spectacle, Non-Custom (Prescription) |
| Regulation | 21 CFR 886.5844 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (56)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935919 | SUNGLASSES | Ja-Ru, Inc. | Feb 16, 1994 | SESE |
| K920795 | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | Optical Radiation Corp. | Jul 13, 1992 | SESE |
| K900091 | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | Onufryk Low Vision Ent. | Apr 4, 1990 | SESE |
| K884360 | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | Seiko Corp. | Nov 15, 1988 | SESE |
| K882814 | NEOLENS PRESCRIPTION SPECTACLE LENS | Neolens, Inc. | Jul 29, 1988 | SESE |
| K882308 | CR-39 PLASTIC LENSES FOR EYEGLASSES | Automated Lens System | Jul 22, 1988 | SESE |
| K881225 | OPHTHALMIC SPECTACLE LENS BLANKS | Beta Optical Co, Inc. | Apr 19, 1988 | SESE |
| K875063 | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. | Epson EL Paso, Inc. | Feb 22, 1988 | SESE |
| K874681 | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES | Klockner Contract Packaging, Inc. | Feb 5, 1988 | SESE |
| K873245 | AR DIACOAT SINGLE VISION LENSES | Seiko Optical Products of America, Inc. | Oct 5, 1987 | SESE |
| K872506 | MELANITE I | Aura Lens Products | Jul 27, 1987 | SESE |
| K871961 | MULTIPLE SPECTACLE LENS | Korea Asahi Optical Co., Ltd. | Jun 3, 1987 | SESE |
| K865103 | KROM-X LENS SYSTEM | Neo Optics, Inc. | Jan 20, 1987 | SESE |
| K863367 | FORMALENS 2000 | Vision-Sciences, Inc. | Sep 26, 1986 | SN |
| K862578 | TECHNA VISION CASTING RESIN | Techna Vision | Jul 23, 1986 | SESE |
| K861021 | GOTTEX SUNGLASSES | Private Eyes Sunglass Corp. | Jun 17, 1986 | SESE |
| K861960 | ZIMLITE LENS | Asahi Optical Co. C/O Rosati Associates, P.C. | Jun 9, 1986 | SESE |
| K861759 | GIRARD SUNGLASSES (NON-PRESCRIPTION) | H. Girard S.A. | Jun 9, 1986 | SESE |
| K861684 | SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) | Seiko Optical Products of America, Inc. | Jun 9, 1986 | SESE |
| K861162 | LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) | Efop | Jun 9, 1986 | SESE |
| K860794 | WRAPPERS, SUNGLASSES | Mhci Corp. | Apr 21, 1986 | SESE |
| K860955 | SPECTACLES LENS | Roseburg SA | Mar 31, 1986 | SESE |
| K854218 | THE ULTRA-MATE LENS | Optical Systems Intl., Inc. | Nov 12, 1985 | SESE |
| K851410 | O.M.S. UV-COLOURS | Optical Moulding Systems | Aug 27, 1985 | SESE |
| K852403 | AURALITE II | Aura Lens Products | Aug 20, 1985 | SESE |
| K853110 | SPECTACLE PRESCRIPTION LENSES | Ancie Laboratories | Aug 9, 1985 | SESE |
| K851163 | SUNGLASES | Full See Glasses Ind. Co., Ltd. | May 30, 1985 | SESE |
| K850905 | CR-39 TYPE RESIN | Orplex Corp. | Mar 20, 1985 | SESE |
| K844778 | SUNGLASSES | B & M Sporting Goods, Inc. | Jan 4, 1985 | SESE |
| K842189 | MULTIPLE LENS, SPECTACLES CUSTOM | Hanmy Optical Industrial Co. | Dec 11, 1984 | SESE |
| K842187 | MULTIPLE LENS, SPECTACLES, CUSTOM | Pavuna , Ltd. | Dec 11, 1984 | SESE |
| K844321 | CUSTOM LITE | Buchmann Optical Industries | Nov 27, 1984 | SESE |
| K843096 | CRISTY/COTE | Titmus Optical, Inc. | Nov 21, 1984 | SESE |
| K841248 | SUNGLASSES | China Toy & Novelty Co., Ltd. | Jul 27, 1984 | SESE |
| K833259 | MULTIPLE | Sun House Products Co. | Apr 2, 1984 | SESE |
| K823825 | NOSITE UV INTERIM SPECTACLES | Patton, Boggs & Blow | Feb 24, 1983 | SESE |
| K822573 | SUNGLASS LENSES | ZEISS | Oct 22, 1982 | SESE |
| K821398 | CORNING CPF 550 LENS | Corning Medical & Scientific | Jun 25, 1982 | SESE |
| K813130 | SUNGLASSES | Panlin Corp. | Mar 4, 1982 | SESE |
| K812441 | DI-CROWN | Coburn Optical Ind., Inc. | Oct 6, 1981 | SESE |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | American Optical Corp. | Sep 8, 1981 | SESE |
| K811554 | BARNES-HIND SPECTACLE LENS CLEANER | Barnes-Hind, Inc. | Jul 2, 1981 | SESE |
| K802749 | BLENDED BIFOCAL | Robinson-Houchin, Inc. | Dec 17, 1980 | SESE |
| K802651 | POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) | Chiron Vision Corp. | Dec 17, 1980 | SESE |
| K800521 | THE LENS OR OMMI-GARD | Gentex Corporation | Mar 12, 1980 | SESE |
| K791901 | BARNES-HIND WETTING & SOAKING SOLUTION | Barnes-Hind, Inc. | Nov 16, 1979 | SESE |
| K791721 | ULTRAVUE BLENDED BIFOCAL LENS | American Optical Corp. | Oct 23, 1979 | SESE |
| K790251 | FUL-VUE ASPHERIC CATARACT LENS | American Optical Corp. | Feb 26, 1979 | SESE |
| K790215 | LENS, POLYCORE | Polycore Optical Pte , Ltd. | Feb 26, 1979 | SESE |
| K781927 | HUMAN II LENS | Spectra-Shield, Inc. | Dec 20, 1978 | SESE |
| K772221 | LENS, HARD RESIN | Borani Intl. | Jan 30, 1978 | SESE |
| K772124 | LENSES, EYEGLASS, SAFETY | Techsight Corp. | Nov 16, 1977 | SESE |
| K772044 | TECHSIGHT LENSES WITH ZUMA COATING | Techsight Corp. | Nov 9, 1977 | SESE |
| K772024 | RX LENS SERIES | Gentex Corporation | Nov 9, 1977 | SESE |
| K770955 | MIRACLELENS | M.R.M. Optics, Inc. | Jun 17, 1977 | SESE |
| K761163 | AD7 PLASTIC MULTIFOCAL EYEGLASS LENS | American Optical Corp. | Dec 16, 1976 | SESE |
Top Applicants
- American Optical Corp. — 4 clearances
- Techsight Corp. — 2 clearances
- Seiko Optical Products of America, Inc. — 2 clearances
- Gentex Corporation — 2 clearances
- Barnes-Hind, Inc. — 2 clearances
