# K180396: miraDry System

- Pathway: 510(k) (Special)
- Applicant: Miramar Labs, Inc.
- Decided: Mar 15, 2018 after 30 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K861904 (1986). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160141: miraDry System, Miramar Labs, Inc. (2016) Summary page 4.

## 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. When used with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.

Source page: https://510kreport.com/device/K180396
Methodology: https://510kreport.com/methodology