Instrument For Treatment Of Hyperhidrosis

Product Code: OUB

General & Plastic Surgery Microwave Medical Products

Definition: Soft-tissue Coagulation.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4400


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as OUB

5826Instrument For Treatment Of HyperhidrosisElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5826Instrument For Treatment Of HyperhidrosisElectrosurgical Cutting And Coagulation Device And Accessories.

Pre-market Notifications for OUB

K150419MiraDry System MD4000MIRAMAR LABS, INC.
K131162MIRADRY SYSTEMMIRAMAR LABS, INC.
K103014MIRADRY SYSTEMMIRAMAR LABS, INC.

Maude Adverse Events

MIRADRY SYSTEMSIENTRA, INC.2020-03-27
MIRADRY SYSTEMSIENTRA, INC.2020-03-27
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MIRADRYSIENTRA / MIRADRY, INC.2019-10-11
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MIRADRY SYSTEMMIRADRY, INC.2019-09-09
MIRADRY SYSTEMMIRADRY, INC.2019-09-09
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MIRADRY SYSTEMMIRADRY, INC.2019-09-06
MIRADRY SYSTEMMIRADRY, INC.2019-09-06

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