HQS
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Burr, Corneal, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4070
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| HYDROBRUSH (TM) KERATOME (K971078) | Medjet, Inc. | 1998-01-23 | + Add |
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