OUB
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument For Treatment Of Hyperhidrosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- Soft-tissue coagulation
- Adverse events (MAUDE)
- 2020: 39 · 2022: 41 · 2023: 49 · 2024: 20 · 2025: 52 · 2026: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| miraDry System MD4000 (K150419) | Miramar Labs, Inc. | 2015-06-19 |
| MIRADRY SYSTEM (K131162) | Miramar Labs, Inc. | 2013-10-25 |
| MIRADRY SYSTEM (K103014) | Miramar Labs, Inc. | 2011-01-28 |
Track OUB automatically
Every clearance here is in the API, with alerts when new ones post.