Product code HQH
- Device name
- Eye, Artificial, Non-Custom
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.3200
- 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 |
|---|---|---|---|
| K952538 | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | 1995-06-26 |
| K945270 | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | 1995-05-30 |
| K946226 | CUSTOM OCULAR PROSTHESIS | Frank Tanaka, Ocularist, Inc. | 1995-03-22 |
| K923167 | THE NISSEL ARTIFICIAL EYE | Nissel , Ltd. | 1992-09-02 |
| K904962 | EYE ARTIFICIAL CUSTOM | Midwest Eye Laboratories, Inc. | 1991-08-30 |
| K791923 | SCLERAL POWDER | Ocularists , Ltd. | 1980-01-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| PROSV2623 | Soper Brothers Custom | Soper Brothers, Incorporated | 2026-03-03 |
| SHELLV2627 | Soper Brothers Custom | Soper Brothers, Incorporated | 2026-03-03 |
| G568V2623 | Artificial Eye, Plastic, Custom | THOMPSON OCULAR PROSTHETICS, INC. | 2025-03-10 |
| B796V2623 | Eye, Artificial, Non-Custom | MIDWEST EYE LABORATORIES, INC. | 2024-03-27 |
| G601350T0 | Sil-Ophtho | SIL-OPHTHO, LLC | 2024-03-14 |
| G6013500 | Sil-Ophtho | SIL-OPHTHO, LLC | 2024-03-14 |
| G601100T0 | Sil-Ophtho | SIL-OPHTHO, LLC | 2024-03-14 |
| G6011000 | Sil-Ophtho | SIL-OPHTHO, LLC | 2024-03-14 |
| G519V2623 | Eye, Artificial, Non-Custom | Midwest Eye Laboratories Sioux Falls, LLC | 2024-03-10 |
| G290V2623 | Eye, Artificial, Non-Custom | Midwest Eye Laboratories Woodbury, LLC | 2024-02-19 |
| G542V26230 | Artificial Eye | THE EYE CONCERN, INC. | 2024-01-10 |
| G521V2623 | Artificial Eye, Plastic, Custom | Legrand Associates | 2023-10-18 |
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