Company ยท US
Miramar Labs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2018. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 15, 2018 | K180396 | miraDry System Miramar Labs, Inc. | NEY |
| Oct 31, 2016 | K160141 | miraDry System Miramar Labs, Inc. | NEY |
| Jun 19, 2015 | K150419 | miraDry System MD4000 Miramar Labs, Inc. | OUB |
| Oct 25, 2013 | K131162 | MIRADRY SYSTEM Miramar Labs, Inc. | OUB |
| Jan 28, 2011 | K103014 | MIRADRY SYSTEM Miramar Labs, Inc. | OUB |
| Mar 20, 2009 | K082819 | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 Miramar Labs, Inc. | NEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Miramar Labs, Inc. miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories.
General and Plastic Surgery: The miraDry System is intended for Terminated |
OUB | K103014 K131162 +1 |
| Jun 17, 2011 | Miramar Labs, Inc. MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece
(MD3001-HP), the miraDry biotip and the miraDry Treatment Template system.
Miramar Labs, Inc.
445 Indio Way
Sunnyvale, CA 94085
Int Terminated |
OUB | K103014 |