Skin Resurfacing Rf Applicator

Product Code: OUH

General & Plastic Surgery Microwave Medical Products

Definition: Skin Resurfacing.

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 OUH

5827Skin Resurfacing Rf ApplicatorElectrosurgical Cutting And Coagulation Device And Accessories.

Total Product Life Cycle (TPLC) Devices

5827Skin Resurfacing Rf ApplicatorElectrosurgical Cutting And Coagulation Device And Accessories.

Pre-market Notifications for OUH

K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd
K142833INTRAGenJEISYS MEDICAL, INC.
K130501INTENSIFENDYMED MEDICAL LTD
K120513GLOW BY ENDYMEDENDYMED MEDICAL LTD
K101510FRACTIONAL SKIN RESURFACING (FSR) APPLICATORENDYMED MEDICAL LTD

Global Unique Device Identification Database

07290016814286Skin Resurfacing Rf Applicator
07290016814231Skin Resurfacing Rf Applicator
08800017100326Skin Resurfacing Rf Applicator
08800017100234Skin Resurfacing Rf Applicator
08800017100722Skin Resurfacing Rf Applicator
08800017100715Skin Resurfacing Rf Applicator
08800017100647Skin Resurfacing Rf Applicator
18800020101218Skin Resurfacing Rf Applicator
08800023200195Skin Resurfacing Rf Applicator
08800023200171Skin Resurfacing Rf Applicator
08800023200041Skin Resurfacing Rf Applicator
08800023200010Skin Resurfacing Rf Applicator
8800020105035Skin Resurfacing Rf Applicator
07290016814125Skin Resurfacing Rf Applicator
07290016814026Skin Resurfacing Rf Applicator

Maude Adverse Events

SECRET RFUNKNOWN2020-01-22
MEDIDERMA PRO RFMEDICREATIONS2017-07-19
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