510(k) K082819
K082819 is an FDA 510(k) premarket notification submitted by Miramar Labs, Inc. for the device "DERMATOLOGIC TREATMENT SYSTEM (DTS) G2". The FDA issued a decision of Substantially Equivalent on March 20, 2009. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Miramar Labs, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2009
- Date Received
- September 25, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Ablation, Microwave And Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type