Product Code: HQG
FDA class 1
21 CFR 886.5844
Lens, Spectacle, Non-Custom (Prescription)
Ophthalmic
A Non-Custom Prescription Spectacle Lens is a standard ophthalmic lens manufactured to a defined prescription specification, used in spectacle frames to correct refractive errors including myopia, hyperopia, astigmatism, and presbyopia in patients whose visual needs can be met by stock lens parameters. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HQG and is regulated under 21 CFR 886.5844, within the Ophthalmic medical specialty.
510(k)s
56
FEI Numbers
638
Registration Numbers
640
Unique Applicants
48
Years Active
17
Basic Information
- Product Code
- HQG
- Device Class
- FDA class 1
- Regulation Number
- 886.5844
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 56 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935919 | SUNGLASSES | Feb 16, 1994 | Substantially Equivalent | JA-RU, INC. |
| K920795 | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | Jul 13, 1992 | Substantially Equivalent | OPTICAL RADIATION CORP. |
| K900091 | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | Apr 04, 1990 | Substantially Equivalent | ONUFRYK LOW VISION ENT. |
| K884360 | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | Nov 15, 1988 | Substantially Equivalent | SEIKO CORP. |
| K882814 | NEOLENS PRESCRIPTION SPECTACLE LENS | Jul 29, 1988 | Substantially Equivalent | NEOLENS, INC. |
| K882308 | CR-39 PLASTIC LENSES FOR EYEGLASSES | Jul 22, 1988 | Substantially Equivalent | AUTOMATED LENS SYSTEM |
| K881225 | OPHTHALMIC SPECTACLE LENS BLANKS | Apr 19, 1988 | Substantially Equivalent | BETA OPTICAL CO, INC. |
| K875063 | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. | Feb 22, 1988 | Substantially Equivalent | EPSON EL PASO, INC. |
| K874681 | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES | Feb 05, 1988 | Substantially Equivalent | KLOCKNER CONTRACT PACKAGING, INC. |
| K873245 | AR DIACOAT SINGLE VISION LENSES | Oct 05, 1987 | Substantially Equivalent | SEIKO OPTICAL PRODUCTS OF AMERICA, INC. |
| K872506 | MELANITE I | Jul 27, 1987 | Substantially Equivalent | AURA LENS PRODUCTS |
| K871961 | MULTIPLE SPECTACLE LENS | Jun 03, 1987 | Substantially Equivalent | KOREA ASAHI OPTICAL CO., LTD. |
| K865103 | KROM-X LENS SYSTEM | Jan 20, 1987 | Substantially Equivalent | NEO OPTICS, INC. |
| K863367 | FORMALENS 2000 | Sep 26, 1986 | Substantially Equivalent for Some Indications | VISION-SCIENCES, INC. |
| K862578 | TECHNA VISION CASTING RESIN | Jul 23, 1986 | Substantially Equivalent | TECHNA VISION |
| K861021 | GOTTEX SUNGLASSES | Jun 17, 1986 | Substantially Equivalent | PRIVATE EYES SUNGLASS CORP. |
| K861960 | ZIMLITE LENS | Jun 09, 1986 | Substantially Equivalent | ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. |
| K861759 | GIRARD SUNGLASSES (NON-PRESCRIPTION) | Jun 09, 1986 | Substantially Equivalent | H. GIRARD S.A. |
| K861684 | SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) | Jun 09, 1986 | Substantially Equivalent | SEIKO OPTICAL PRODUCTS OF AMERICA, INC. |
| K861162 | LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) | Jun 09, 1986 | Substantially Equivalent | EFOP |
| K860794 | WRAPPERS, SUNGLASSES | Apr 21, 1986 | Substantially Equivalent | MHCI CORP. |
| K860955 | SPECTACLES LENS | Mar 31, 1986 | Substantially Equivalent | ROSEBURG SA |
| K854218 | THE ULTRA-MATE LENS | Nov 12, 1985 | Substantially Equivalent | OPTICAL SYSTEMS INTL., INC. |
| K851410 | O.M.S. UV-COLOURS | Aug 27, 1985 | Substantially Equivalent | OPTICAL MOULDING SYSTEMS |
| K852403 | AURALITE II | Aug 20, 1985 | Substantially Equivalent | AURA LENS PRODUCTS |
| K853110 | SPECTACLE PRESCRIPTION LENSES | Aug 09, 1985 | Substantially Equivalent | ANCIE LABORATORIES |
| K851163 | SUNGLASES | May 30, 1985 | Substantially Equivalent | FULL SEE GLASSES IND. CO., LTD. |
| K850905 | CR-39 TYPE RESIN | Mar 20, 1985 | Substantially Equivalent | ORPLEX CORP. |
| K844778 | SUNGLASSES | Jan 04, 1985 | Substantially Equivalent | B & M SPORTING GOODS, INC. |
| K842189 | MULTIPLE LENS, SPECTACLES CUSTOM | Dec 11, 1984 | Substantially Equivalent | HANMY OPTICAL INDUSTRIAL CO. |
| K842187 | MULTIPLE LENS, SPECTACLES, CUSTOM | Dec 11, 1984 | Substantially Equivalent | PAVUNA LTD. |
| K844321 | CUSTOM LITE | Nov 27, 1984 | Substantially Equivalent | BUCHMANN OPTICAL INDUSTRIES |
| K843096 | CRISTY/COTE | Nov 21, 1984 | Substantially Equivalent | TITMUS OPTICAL, INC. |
| K841248 | SUNGLASSES | Jul 27, 1984 | Substantially Equivalent | CHINA TOY & NOVELTY CO., LTD. |
| K833259 | MULTIPLE | Apr 02, 1984 | Substantially Equivalent | SUN HOUSE PRODUCTS CO. |
| K823825 | NOSITE UV INTERIM SPECTACLES | Feb 24, 1983 | Substantially Equivalent | PATTON, BOGGS & BLOW |
| K822573 | SUNGLASS LENSES | Oct 22, 1982 | Substantially Equivalent | ZEISS |
| K821398 | CORNING CPF 550 LENS | Jun 25, 1982 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K813130 | SUNGLASSES | Mar 04, 1982 | Substantially Equivalent | PANLIN CORP. |
| K812441 | DI-CROWN | Oct 06, 1981 | Substantially Equivalent | COBURN OPTICAL IND., INC. |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | Sep 08, 1981 | Substantially Equivalent | AMERICAN OPTICAL CORP. |
| K811554 | BARNES-HIND SPECTACLE LENS CLEANER | Jul 02, 1981 | Substantially Equivalent | BARNES-HIND, INC. |
| K802749 | BLENDED BIFOCAL | Dec 17, 1980 | Substantially Equivalent | ROBINSON-HOUCHIN, INC. |
| K802651 | POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) | Dec 17, 1980 | Substantially Equivalent | CHIRON VISION CORP. |
| K800521 | THE LENS OR OMMI-GARD | Mar 12, 1980 | Substantially Equivalent | GENTEX CORPORATION |
| K791901 | BARNES-HIND WETTING & SOAKING SOLUTION | Nov 16, 1979 | Substantially Equivalent | BARNES-HIND, INC. |
| K791721 | ULTRAVUE BLENDED BIFOCAL LENS | Oct 23, 1979 | Substantially Equivalent | AMERICAN OPTICAL CORP. |
| K790251 | FUL-VUE ASPHERIC CATARACT LENS | Feb 26, 1979 | Substantially Equivalent | AMERICAN OPTICAL CORP. |
| K790215 | LENS, POLYCORE | Feb 26, 1979 | Substantially Equivalent | POLYCORE OPTICAL PTE LTD. |
| K781927 | HUMAN II LENS | Dec 20, 1978 | Substantially Equivalent | SPECTRA-SHIELD, INC. |
| K772221 | LENS, HARD RESIN | Jan 30, 1978 | Substantially Equivalent | BORANI INTL. |
| K772124 | LENSES, EYEGLASS, SAFETY | Nov 16, 1977 | Substantially Equivalent | TECHSIGHT CORP. |
| K772044 | TECHSIGHT LENSES WITH ZUMA COATING | Nov 09, 1977 | Substantially Equivalent | TECHSIGHT CORP. |
| K772024 | RX LENS SERIES | Nov 09, 1977 | Substantially Equivalent | GENTEX CORPORATION |
| K770955 | MIRACLELENS | Jun 17, 1977 | Substantially Equivalent | M.R.M. OPTICS, INC. |
| K761163 | AD7 PLASTIC MULTIFOCAL EYEGLASS LENS | Dec 16, 1976 | Substantially Equivalent | AMERICAN OPTICAL CORP. |
FEI Numbers
This FDA classification entry is associated with 638 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 640 registration numbers. Click on an entry to view related FDA registrations.