Product code HJH
- Device name
- Loupe, Binocular, Low Power
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.5120
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06945095542049 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095548096 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095544722 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095544289 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095543732 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542148 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542131 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542124 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542117 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542100 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542094 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542087 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542070 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542063 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542056 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541110 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542032 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542025 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542018 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095542001 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541998 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541981 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541974 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541967 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541950 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541943 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541936 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541929 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541448 | zumax | Zumax Medical Co., LTD | 2026-06-03 |
| 06945095541424 | zumax | Zumax Medical Co., LTD | 2026-06-03 |