510(k) K131162 ยท OUB Instrument For Treatment Of Hyperhidrosis
MIRADRY SYSTEM
| Applicant | Miramar Labs, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 25, 2013 |
| Received | Apr 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131162
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.