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 |