Panels › General, Plastic Surgery › Product code OUB · Class 2
Instrument For Treatment Of Hyperhidrosis
Regulation 878.4400
0510(k)s in 12 months (3 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OUB
| Company | 510(k)s | Recalls |
|---|---|---|
| Miramar Labs, Inc. | 3 | 2 |
| 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 |
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