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 |
|---|---|---|---|
| 06945095547044 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547235 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547228 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547181 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547174 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547167 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547150 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547143 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547136 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547129 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547112 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547105 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547082 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547068 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547051 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546818 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547020 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547013 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095547006 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546986 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546962 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546955 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546948 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546900 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546894 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546887 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546863 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546856 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546832 | zumax | Zumax Medical Co., LTD | 2026-06-01 |
| 06945095546825 | zumax | Zumax Medical Co., LTD | 2026-06-01 |