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 |
|---|---|---|---|
| 06945095556718 | zumax | Zumax Medical Co., LTD | 2026-10-09 |
| 06945095557005 | zumax | Zumax Medical Co., LTD | 2026-10-09 |
| 06945095557012 | zumax | Zumax Medical Co., LTD | 2026-10-09 |
| 06945095557029 | zumax | Zumax Medical Co., LTD | 2026-10-09 |
| 06945095556701 | zumax | Zumax Medical Co., LTD | 2026-10-09 |
| 06945095557067 | zumax | Zumax Medical Co., LTD | 2026-09-29 |
| 06945095557074 | zumax | Zumax Medical Co., LTD | 2026-09-29 |
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