HQZ · Frame, Spectacle
Ophthalmic · 21 CFR 886.5842 · Class 1
Overview
| Product Code | HQZ |
|---|---|
| Device Name | Frame, Spectacle |
| Regulation | 21 CFR 886.5842 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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 | 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 | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | Mar 28, 1995 | SESE |
| K945770 | OPTICAL FRAMES | Ramada Optics, Inc. | Dec 15, 1994 | SESE |
| K945392 | SPECTACLE FRAME | Seo Han Corp., Ltd. | Dec 15, 1994 | SESE |
| K945176 | SPECTACLE FRAME OR EYEGLASS FRAMES | Optipia Trading Co. | Dec 15, 1994 | SESE |
| K945350 | FRAME, SPECTACLES | Taiwan Eva Industrial Co., Inc. | Dec 13, 1994 | SESE |
| K945342 | MAG-1 SPECTACLE FRAME | Criss Optical Mfg. Co., Inc. | Nov 28, 1994 | SESE |
| K945450 | FRAME, SPECTACLE | Kookje Apis Industrial Co. | Nov 22, 1994 | SESE |
| K945340 | SPECTACLE FRAMES OR EYEGLASS FRAMES | Mi Mun Corp. | Nov 22, 1994 | SESE |
| K945323 | SPECTACLE FRAME | M.Y. Vision Corp. | Nov 22, 1994 | SESE |
| K945123 | ARISTAR EYEWEAR, ESPRIT EYEWEAR | Aristar Inc. U.S.A. | Nov 22, 1994 | SESE |
| K944641 | NIL | Max-Vision (H.K.)Limited | Nov 14, 1994 | SESE |
| K944373 | SPECTACLE FRAMES | Custom Optical Frames, Inc. | Sep 28, 1994 | SESE |
| K944160 | SILHOUETTE, SUNLIMETED,ADIDAS | Silhouette Optical , Ltd. | Sep 28, 1994 | SESE |
| K943792 | SPECTACLE FRAMES | Kt Optique, Inc. | Sep 14, 1994 | SESE |
| K943641 | SPECTACLE FRAME | Australian Optical Co., Inc. | Sep 14, 1994 | SESE |
| K943561 | SPECTACLE FRAME | Australian Optical Co., Inc. | Sep 14, 1994 | SESE |
| K943913 | MAX FRAME DESIGN | Noble Optic | Sep 7, 1994 | SESE |
| K943423 | SPECTACLE FRAMES | Galilee Optics | Sep 6, 1994 | SESE |
| K943753 | 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
