# K150419: miraDry System MD4000

- Pathway: 510(k) (Traditional)
- Applicant: Miramar Labs, Inc.
- Decided: Jun 19, 2015 after 121 days
- Product code: OUB (Instrument For Treatment Of Hyperhidrosis)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K861904 (1986). 23 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131162: Miradry System, Miramar Labs, Inc. (2013) Summary page 5.

## Most influential descendants
- K160141: miraDry System (2016), 1 descendant of its own
- K180396: miraDry System (2018), 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.

## Indications for use
The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I – IV. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K150419
Methodology: https://510kreport.com/methodology