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510(k) K180396

miraDry System by Miramar Labs, Inc. — Product Code NEY

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

Other clearances by Miramar Labs, Inc.

  • K160141 — miraDry System (October 31, 2016)
  • K150419 — miraDry System MD4000 (June 19, 2015)
  • K131162 — MIRADRY SYSTEM (October 25, 2013)
  • K103014 — MIRADRY SYSTEM (January 28, 2011)
  • K082819 — DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 (March 20, 2009)

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