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Miramar Labs, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0234-2016Class IImiraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-October 9, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K180396miraDry SystemMarch 15, 2018
K160141miraDry SystemOctober 31, 2016
K150419miraDry System MD4000June 19, 2015
K131162MIRADRY SYSTEMOctober 25, 2013
K103014MIRADRY SYSTEMJanuary 28, 2011
K082819DERMATOLOGIC TREATMENT SYSTEM (DTS) G2March 20, 2009