510(k) K214008

Device
Dental diode laser
Applicant
Shenzhen Soga Technology Co., Ltd.
510(k) number
K214008
Product code
NVK
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-10
Date received
2021-12-22
Regulation
878.4810
Classification name
Laser, Dental, Soft Tissue
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tse Adrian
Address
D906, Yinxing Technology Bldg. # 1301, Sightseeing Rd. Xinlan Community, Guanlan St., Longhua District Shenzhen CN 518110 518110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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