Miradry System
by Miramar Labs, Inc. 4 variants
510(k) K103014
Miradry System is a medical device (FDA Class II; FDA product code OUB, Instrument For Treatment Of Hyperhidrosis) made by Miramar Labs, Inc., cleared under FDA 510(k) K103014 on 28 Jan 2011, active as of 11 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103014 | Date28 Jan 2011 | StatusActive |
Official records
- FDA 510(k) database K103014
Recalls
-
- Terminated Z-0234-2016
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.
-
- Terminated Z-2591-2011
Reports of skin burns on axilla after treatment with the miraDry System.
Timeline
- Cleared FDA 510(k) K103014
- Recall initiated FDA recalls Z-2591-2011
- Recall initiated FDA recalls Z-0234-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OUB
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent