Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5842](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5842) → HQZ — Frame, Spectacle # HQZ · Frame, Spectacle _Ophthalmic · 21 CFR 886.5842 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ ## Overview - **Product Code:** HQZ - **Device Name:** Frame, Spectacle - **Regulation:** [21 CFR 886.5842](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5842) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) ## Identification A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors. ## 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 198) Showing 20 most recent of 198 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K952597](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K952597.md) | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW | Point of View Optical Outlet, Inc. | Sep 12, 1995 | SESE | | [K944313](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K944313.md) | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | Mar 28, 1995 | SESE | | [K945770](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945770.md) | OPTICAL FRAMES | Ramada Optics, Inc. | Dec 15, 1994 | SESE | | [K945392](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945392.md) | SPECTACLE FRAME | Seo Han Corp., Ltd. | Dec 15, 1994 | SESE | | [K945176](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945176.md) | SPECTACLE FRAME OR EYEGLASS FRAMES | Optipia Trading Co. | Dec 15, 1994 | SESE | | [K945350](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945350.md) | FRAME, SPECTACLES | Taiwan Eva Industrial Co., Inc. | Dec 13, 1994 | SESE | | [K945342](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945342.md) | MAG-1 SPECTACLE FRAME | Criss Optical Mfg. Co., Inc. | Nov 28, 1994 | SESE | | [K945450](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945450.md) | FRAME, SPECTACLE | Kookje Apis Industrial Co. | Nov 22, 1994 | SESE | | [K945340](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945340.md) | SPECTACLE FRAMES OR EYEGLASS FRAMES | Mi Mun Corp. | Nov 22, 1994 | SESE | | [K945323](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945323.md) | SPECTACLE FRAME | M.Y. Vision Corp. | Nov 22, 1994 | SESE | | [K945123](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K945123.md) | ARISTAR EYEWEAR, ESPRIT EYEWEAR | Aristar Inc. U.S.A. | Nov 22, 1994 | SESE | | [K944641](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K944641.md) | NIL | Max-Vision (H.K.)Limited | Nov 14, 1994 | SESE | | [K944373](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K944373.md) | SPECTACLE FRAMES | Custom Optical Frames, Inc. | Sep 28, 1994 | SESE | | [K944160](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K944160.md) | SILHOUETTE, SUNLIMETED,ADIDAS | Silhouette Optical , Ltd. | Sep 28, 1994 | SESE | | [K943792](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K943792.md) | SPECTACLE FRAMES | Kt Optique, Inc. | Sep 14, 1994 | SESE | | [K943641](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K943641.md) | SPECTACLE FRAME | Australian Optical Co., Inc. | Sep 14, 1994 | SESE | | [K943561](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K943561.md) | SPECTACLE FRAME | Australian Optical Co., Inc. | Sep 14, 1994 | SESE | | [K943913](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K943913.md) | MAX FRAME DESIGN | Noble Optic | Sep 7, 1994 | SESE | | [K943423](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K943423.md) | SPECTACLE FRAMES | Galilee Optics | Sep 6, 1994 | SESE | | [K943753](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K943753.md) | FRAME SPECTACLE | Optic Tech Corp. | Sep 2, 1994 | SESE | ## Top Applicants - Australian Optical Co., Inc. — 5 clearances - Frontier Novelty, Inc. — 4 clearances - South West Intl., Inc. — 4 clearances - Roseburg SA — 3 clearances - Atlantic Optical Co., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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