510(k) K103014 ยท OUB Instrument For Treatment Of Hyperhidrosis
MIRADRY SYSTEM
| Applicant | Miramar Labs, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 28, 2011 |
| Received | Oct 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103014
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.