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Miradry System

by Miramar Labs, Inc. 4 variants

510(k) K131162

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) K131162 on 25 Oct 2013, active as of 9 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131162 Date25 Oct 2013ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0234-2016 FDA Class II initiated 9 Oct 2015

    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.

Timeline

2 dated events

  1. Cleared FDA 510(k) K131162
  2. Recall initiated FDA recalls Z-0234-2016

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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