Product code HOI
- Device name
- Spectacle, Magnifying
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.5840
- 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 |
|---|---|---|---|
| K943613 | NIL | Sing Wah International Enterprises , Ltd. | 1994-09-21 |
| K930435 | SPECTACLE FRAMES | Venis DI A. Vendrame | 1993-09-20 |
| K931328 | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | Pyramid | 1993-08-10 |
| K910329 | SUNGLASSES | Cutler & Gross Sloan Optical , Ltd. | 1991-03-12 |
| K854854 | SYSTEMS OF SIGHT LOW VISION EYEWARE | Int'L Eye Care, Inc. | 1986-02-04 |
| K844716 | MAGNIFYING SPECTACLES W/PLASTIC LENSES | Gazelle Corp. | 1985-01-03 |
| K844038 | VISITEC MAGNIFYING SPECTACLES | Visitec Co. | 1984-11-29 |
| K842835 | BRILLETTE MODEL | Cillus Company, Inc. | 1984-11-21 |
| K820732 | LA VEL LATERAL VIEW EXTENSION LENS | Peter M. Tolliver | 1982-05-03 |
| K813548 | UVEX MINI-SPECS | Bacou USA, Inc. and Uvex Safety, Inc. | 1982-03-02 |
| K801733 | FENZL RETICLE | Robert E. Fenzl, M.D. | 1980-09-16 |
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|---|---|---|---|
| 07640288790625 | read on | Read On Inc. | 2023-12-08 |
| 07640288790618 | read on | Read On Inc. | 2023-12-08 |
| 07640288790748 | read on | Read On Inc. | 2023-12-05 |
| 07640288790731 | read on | Read On Inc. | 2023-12-05 |
| 07640288790724 | read on | Read On Inc. | 2023-12-05 |
| 07640288790717 | read on | Read On Inc. | 2023-12-05 |
| 07640288790700 | read on | Read On Inc. | 2023-12-05 |
| 07640288790694 | read on | Read On Inc. | 2023-12-05 |
| 07640288790687 | read on | Read On Inc. | 2023-12-05 |
| 07640288790670 | read on | Read On Inc. | 2023-12-05 |
| 07640288790663 | read on | Read On Inc. | 2023-12-05 |
| 07640288790656 | read on | Read On Inc. | 2023-12-05 |
| 07640288790649 | read on | Read On Inc. | 2023-12-05 |
| 07640288790632 | read on | Read On Inc. | 2023-12-05 |
| 07640288790328 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790106 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790311 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790298 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790281 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790267 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790250 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790236 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790229 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790205 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790199 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790175 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790144 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790137 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790113 | read on | Solsolito GmbH | 2022-12-16 |
| 07640288790168 | read on | Solsolito GmbH | 2022-12-12 |