The following data is part of a premarket notification filed by Miramar Labs, Inc. with the FDA for Miradry System.
| Device ID | K160141 |
| 510k Number | K160141 |
| Device Name: | MiraDry System |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Miramar Labs, Inc. 2790 Walsh Avenue Santa Clara, CA 95051 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Kathy O'shaughnessy Miramar Labs, Inc. 2790 Walsh Avenue Santa Clara, CA 95051 |
| Product Code | NEY |
| Subsequent Product Code | MWY |
| Subsequent Product Code | OUB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-21 |
| Decision Date | 2016-10-31 |
| Summary: | summary |