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.
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| 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 |
Top Applicants
- American Optical Corp. — 4 clearances
- Aura Lens Products — 2 clearances
- Barnes-Hind, Inc. — 2 clearances
- Gentex Corporation — 2 clearances
- Seiko Optical Products of America, Inc. — 2 clearances
