The following data is part of a premarket notification filed by Miramar Labs, Inc. with the FDA for Miradry System.
| Device ID | K131162 |
| 510k Number | K131162 |
| Device Name: | MIRADRY SYSTEM |
| Classification | Instrument For Treatment Of Hyperhidrosis |
| Applicant | MIRAMAR LABS, INC. 445 INDIO WAY Sunnyvale, CA 94085 -4203 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Kathy O'shaughnessy MIRAMAR LABS, INC. 445 INDIO WAY Sunnyvale, CA 94085 -4203 |
| Product Code | OUB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2013-10-25 |
| Summary: | summary |