Product code HQZ
- Device name
- Frame, Spectacle
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.5842
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952597 | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW | Point of View Optical Outlet, Inc. | 1995-09-12 |
| K944313 | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | 1995-03-28 |
| K945770 | OPTICAL FRAMES | Ramada Optics, Inc. | 1994-12-15 |
| K945392 | SPECTACLE FRAME | Seo Han Corp., Ltd. | 1994-12-15 |
| K945176 | SPECTACLE FRAME OR EYEGLASS FRAMES | Optipia Trading Co. | 1994-12-15 |
| K945350 | FRAME, SPECTACLES | Taiwan Eva Industrial Co., Inc. | 1994-12-13 |
| K945342 | MAG-1 SPECTACLE FRAME | Criss Optical Mfg. Co., Inc. | 1994-11-28 |
| K945450 | FRAME, SPECTACLE | Kookje Apis Industrial Co. | 1994-11-22 |
| K945340 | SPECTACLE FRAMES OR EYEGLASS FRAMES | Mi Mun Corp. | 1994-11-22 |
| K945323 | SPECTACLE FRAME | M.Y. Vision Corp. | 1994-11-22 |
| K945123 | ARISTAR EYEWEAR, ESPRIT EYEWEAR | Aristar Inc. U.S.A. | 1994-11-22 |
| K944641 | NIL | Max-Vision (H.K.)Limited | 1994-11-14 |
| K944373 | SPECTACLE FRAMES | Custom Optical Frames, Inc. | 1994-09-28 |
| K944160 | SILHOUETTE, SUNLIMETED,ADIDAS | Silhouette Optical , Ltd. | 1994-09-28 |
| K943561 | SPECTACLE FRAME | Australian Optical Co., Inc. | 1994-09-14 |
| K943792 | SPECTACLE FRAMES | Kt Optique, Inc. | 1994-09-14 |
| K943641 | SPECTACLE FRAME | Australian Optical Co., Inc. | 1994-09-14 |
| K943913 | MAX FRAME DESIGN | Noble Optic | 1994-09-07 |
| K943423 | SPECTACLE FRAMES | Galilee Optics | 1994-09-06 |
| K943753 | FRAME SPECTACLE | Optic Tech Corp. | 1994-09-02 |
| K943567 | FACONNABLE EYEWEAR | Blink Designs, Inc. | 1994-08-10 |
| K943326 | SPECTACLE FRAMES | Buffard-La-Doye | 1994-08-10 |
| K943507 | WINK EYEWEAR | Wink Optical, Inc. | 1994-08-05 |
| K942478 | VISARD FRAMES | Iris Optical, Inc. | 1994-08-05 |
| K943265 | N-REDWALL, DAVID OPTICS, CHRISTIAN LIZA, DMO | The First Optical Manufactory , Ltd. | 1994-08-05 |
| K942897 | OPTHALMIC WIPE | Surgin Surgical Instrumentation, Inc. | 1994-08-05 |
| K943198 | SPECTACLE FRAMES | Lunettes Folomi S.A. | 1994-08-05 |
| K943082 | SPECTACLE FRAME | Daewon Optical Co. | 1994-08-04 |
| K942845 | PERSOL, MOSCLHINO, AND GERALD GENTA | Persol America, Inc. | 1994-08-04 |
| K943085 | SPECTACLE FRAME | Winntics Optical Industry Co. , Ltd. | 1994-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08435304355327 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2024-07-20 |
| 08435304355310 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2024-07-20 |
| 08435304355273 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2024-07-20 |
| 08435304355266 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2024-07-20 |
| 08435304355259 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2024-07-20 |
| 08435304354375 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-23 |
| 08435304347063 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-22 |
| 08435304329533 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304352746 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304348572 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304348053 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304343737 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304343720 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304343713 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304343638 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304343317 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304329021 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304331529 | Etnia Eyewear Culture | Etnia Barcelona, Llc. | 2022-11-16 |
| 08435304347766 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-13 |
| 08435304347773 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-13 |
| 08435304355655 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-13 |
| 08435304355648 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-13 |
| 08435304355600 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-13 |
| 08435304355846 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |
| 08435304355921 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |
| 08435304353606 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |
| 08435304353460 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |
| 08435304351978 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |
| 08435304337422 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |
| 08435304337408 | ETNIA EYEWEAR CULTURE | Etnia Barcelona, Llc. | 2022-11-12 |