510(k) K150419
K150419 is an FDA 510(k) premarket notification submitted by Miramar Labs, Inc. for the device "miraDry System MD4000". The FDA issued a decision of Substantially Equivalent on June 19, 2015. 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
- June 19, 2015
- Date Received
- February 18, 2015
- 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