510(k) K131162
K131162 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 October 25, 2013. The device falls under product code OUB (Instrument For Treatment Of Hyperhidrosis), 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
- October 25, 2013
- Date Received
- April 24, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument For Treatment Of Hyperhidrosis
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Soft-tissue coagulation