OUBClass II
Instrument For Treatment Of Hyperhidrosis
General, Plastic Surgery · 21 CFR 878.4400
Soft-tissue coagulation
MDR events655All time
Recalls2All time
Registered firms4Currently listed
510(k) clearances3All time
Recent MDR events
655 adverse event reports on file
- miraDry SystemJul 30, 2026InjuryMiradry Inc.3008082710-2026-70020
- miraDry SystemJul 30, 2026InjuryMiradry Inc.3008082710-2026-70022
- MIRADRY SYSTEMJul 15, 2026InjuryMiradry Inc.3008082710-2026-70019
- MIRADRY SYSTEMJul 14, 2026InjuryMiradry Inc.3008082710-2026-70018
- MIRADRY SYSTEMJul 3, 2026InjuryMiradry Inc.3008082710-2026-70017
- MIRADRY SYSTEMJul 2, 2026InjuryMiradry Inc.3008082710-2026-70015
- MIRADRY SYSTEMJul 2, 2026InjuryMiradry Inc.3008082710-2026-70016
- MIRADRY SYSTEMJun 3, 2026InjuryMiradry Inc.3008082710-2026-70013
- MIRADRY SYSTEMJun 3, 2026InjuryMiradry Inc.3008082710-2026-70014
- MIRADRY SYSTEMMay 15, 2026InjuryMiradry Inc.3008082710-2026-70011
Event type breakdown
Injury640
Malfunction12
Death2
Unspecified1
Recalls
2 recall events for this product code
- Miramar Labs, Inc.TerminatedNov 6, 2015
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories.
Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
Z-0234-2016 · View FDA record ↗ - Miramar Labs, Inc.TerminatedJun 17, 2011
MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece
Reports of skin burns on axilla after treatment with the miraDry System.
Z-2591-2011 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
3 clearances for this product code