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 |
|---|---|---|---|
| 00814005024233 | EP-4.5 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
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| 00814005024332 | Q-Optics Loupe and Light Combo Case | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005024325 | BRX | QUALITY ASPIRATORS, INC. | 2025-02-27 |
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| 00814005023304 | M-2.5 Flip | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005024226 | EP-4.0 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005024219 | EP-3.5 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005024196 | F-3.0 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023519 | Q879 | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023502 | Q877 | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023496 | Prism Combo Case | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023472 | P-4.5 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023465 | P-4.0 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023458 | P-3.5 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023359 | M-3.5 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023342 | M-3.5 Flip | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023335 | M-3.0 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023328 | M-3.0 Flip | QUALITY ASPIRATORS, INC. | 2025-02-27 |
| 00814005023311 | M-2.5 TTL | QUALITY ASPIRATORS, INC. | 2025-02-27 |