510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131162Substantially Equivalent

Miradry System

miraDry, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131162 is the FDA 510(k) clearance record for MIRADRY SYSTEM, a class II device, cleared for Miramar Labs, Inc. on under FDA product code OUB (Instrument For Treatment Of Hyperhidrosis). FDA's definition for product code OUB reads: "Soft-tissue coagulation". FDA records list 6 510(k) clearances for miraDry, Inc., from to . As of , FDA records show one recall naming K131162.

Clearance record

Decision date
Received
(184 days to decision)
Product code
OUB Instrument For Treatment Of Hyperhidrosis
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Miramar Labs, Inc. 445 Indio Way, Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OUB

Trailing 12 months

FDA records hold no clearances under product code OUB in the trailing twelve months.

FDA records show no clearances under product code OUB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OUB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260