Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5844](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5844) → HQG — Lens, Spectacle, Non-Custom (Prescription) # HQG · Lens, Spectacle, Non-Custom (Prescription) _Ophthalmic · 21 CFR 886.5844 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG ## Overview - **Product Code:** HQG - **Device Name:** Lens, Spectacle, Non-Custom (Prescription) - **Regulation:** [21 CFR 886.5844](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5844) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K935919.md) | SUNGLASSES | Ja-Ru, Inc. | Feb 16, 1994 | SESE | | [K920795](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K920795.md) | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | Optical Radiation Corp. | Jul 13, 1992 | SESE | | [K900091](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K900091.md) | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | Onufryk Low Vision Ent. | Apr 4, 1990 | SESE | | [K884360](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K884360.md) | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | Seiko Corp. | Nov 15, 1988 | SESE | | [K882814](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K882814.md) | NEOLENS PRESCRIPTION SPECTACLE LENS | Neolens, Inc. | Jul 29, 1988 | SESE | | [K882308](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K882308.md) | CR-39 PLASTIC LENSES FOR EYEGLASSES | Automated Lens System | Jul 22, 1988 | SESE | | [K881225](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K881225.md) | OPHTHALMIC SPECTACLE LENS BLANKS | Beta Optical Co, Inc. | Apr 19, 1988 | SESE | | [K875063](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K875063.md) | SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. | Epson EL Paso, Inc. | Feb 22, 1988 | SESE | | [K874681](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K874681.md) | SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES | Klockner Contract Packaging, Inc. | Feb 5, 1988 | SESE | | [K873245](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K873245.md) | AR DIACOAT SINGLE VISION LENSES | Seiko Optical Products of America, Inc. | Oct 5, 1987 | SESE | | [K872506](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K872506.md) | MELANITE I | Aura Lens Products | Jul 27, 1987 | SESE | | [K871961](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K871961.md) | MULTIPLE SPECTACLE LENS | Korea Asahi Optical Co., Ltd. | Jun 3, 1987 | SESE | | [K865103](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K865103.md) | KROM-X LENS SYSTEM | Neo Optics, Inc. | Jan 20, 1987 | SESE | | [K863367](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K863367.md) | FORMALENS 2000 | Vision-Sciences, Inc. | Sep 26, 1986 | SN | | [K862578](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K862578.md) | TECHNA VISION CASTING RESIN | Techna Vision | Jul 23, 1986 | SESE | | [K861021](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K861021.md) | GOTTEX SUNGLASSES | Private Eyes Sunglass Corp. | Jun 17, 1986 | SESE | | [K861960](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K861960.md) | ZIMLITE LENS | Asahi Optical Co. C/O Rosati Associates, P.C. | Jun 9, 1986 | SESE | | [K861759](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K861759.md) | GIRARD SUNGLASSES (NON-PRESCRIPTION) | H. Girard S.A. | Jun 9, 1986 | SESE | | [K861684](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K861684.md) | SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) | Seiko Optical Products of America, Inc. | Jun 9, 1986 | SESE | | [K861162](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K861162.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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