FDA.reportPublic FDA data

510(k) K240758

Device
Radiofrequency Generator System, Cura RF Electrode
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
510(k) number
K240758
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-11
Date received
2024-03-20
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ruiran Song
Address
Rm. 106, Bldg. 1, # 600, 21st Ave., Baiyang Sub-District, Qi Hangzhou CN 310018 310018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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