# Miramar Labs, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 6 (2009–2018): 6 510(k) clearances
- Product codes: NEY (3), OUB (3)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Foundry Newco X, Inc.: 1 (https://510kreport.com/company/foundry-newco-x)

## Firms that cite its devices most
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Emblation, Ltd.: 1 (https://510kreport.com/company/emblation)

## Its most-cited devices
- K103014: Miradry System (2011), cited by 2
- K082819: Dermatologic Treatment System (DTS) G2 (2009), cited by 2
- K160141: miraDry System (2016), cited by 1
- K131162: Miradry System (2013), cited by 1
- K150419: miraDry System MD4000 (2015), cited by 1

## Recent decisions
- K180396: miraDry System (Mar 15, 2018)
- K160141: miraDry System (Oct 31, 2016)
- K150419: miraDry System MD4000 (Jun 19, 2015)
- K131162: Miradry System (Oct 25, 2013)
- K103014: Miradry System (Jan 28, 2011)
- K082819: Dermatologic Treatment System (DTS) G2 (Mar 20, 2009)

Source page: https://510kreport.com/company/miramar-labs