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Instrument For Treatment Of Hyperhidrosis

FDA product code OUB · Class 2 · General, Plastic Surgery

4
Registered devices
655
Adverse events
2
Recalls
3
510(k) clearances

Devices with this code

miraDry — MIRADRY, INC.miraDry — MIRADRY, INC.miraDry — MIRADRY, INC.miraDry — MIRADRY, INC.

Recent recalls

DateFirmReason
2015-10-09Miramar Labs, Inc.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.
2011-04-24Miramar Labs, Inc.Reports of skin burns on axilla after treatment with the miraDry System.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.