The following data is part of a premarket notification filed by Miramar Labs, Inc. with the FDA for Dermatologic Treatment System (dts) G2.
| Device ID | K082819 |
| 510k Number | K082819 |
| Device Name: | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | MIRAMAR LABS, INC. 199 JEFFERSON DR. Menlo Park, CA 94025 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Kathy O'shaughnessy MIRAMAR LABS, INC. 199 JEFFERSON DR. Menlo Park, CA 94025 |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2009-03-20 |
| Summary: | summary |