Home / 510(k) Clearances / K150419

510(k) K150419

miraDry System MD4000 by Miramar Labs, Inc. — Product Code OUB

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

Other clearances by Miramar Labs, Inc.

  • K180396 — miraDry System (March 15, 2018)
  • K160141 — miraDry System (October 31, 2016)
  • K131162 — MIRADRY SYSTEM (October 25, 2013)
  • K103014 — MIRADRY SYSTEM (January 28, 2011)
  • K082819 — DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 (March 20, 2009)

Other clearances for product code OUB

  • K131162 — MIRADRY SYSTEM (October 25, 2013)
  • K103014 — MIRADRY SYSTEM (January 28, 2011)