510(k) K180396
K180396 is an FDA 510(k) premarket notification submitted by Miramar Labs, Inc. for the device "miraDry System". The FDA issued a decision of Substantially Equivalent on March 15, 2018. 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 15, 2018
- Date Received
- February 13, 2018
- Clearance Type
- Special
- 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