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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| 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 |
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