# K103014: Miradry System

- Pathway: 510(k) (Traditional)
- Applicant: Miramar Labs, Inc.
- Decided: Jan 28, 2011 after 107 days
- Product code: OUB (Instrument For Treatment Of Hyperhidrosis)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K861904 (1986). 21 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082819: Dermatologic Treatment System (DTS) G2, Miramar Labs, Inc. (2009) Summary page 1.

## Most influential descendants
- K131162: Miradry System (2013), 3 descendants of its own
- K150419: miraDry System MD4000 (2015), 2 descendants of its own
- K160141: miraDry System (2016), 1 descendant of its own
- K180396: miraDry System (2018), 0 descendants of its own
- K141511: SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength Lasers (2015), 0 descendants of its own

## Recalls of this device
- Oct 9, 2015 · Class II · 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.
- Apr 24, 2011 · Not classified · Z-2591-2011: Reports of skin burns on axilla after treatment with the miraDry System.

## Indications for use
The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis. Note: The miraDry System is not indicated for use in the treatment of hyperhidrosis related to other body areas or generalized hyperhidrosis.

Source page: https://510kreport.com/device/K103014
Methodology: https://510kreport.com/methodology