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OUB — Instrument For Treatment Of Hyperhidrosis Class II

FDA Device Classification

Classification Details

Product Code
OUB
Device Class
Class II
Regulation Number
878.4400
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Soft-tissue coagulation

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150419miramar labsmiraDry System MD4000June 19, 2015
K131162miramar labsMIRADRY SYSTEMOctober 25, 2013
K103014miramar labsMIRADRY SYSTEMJanuary 28, 2011