FDA.report

510(k) K242908

Device
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
Applicant
Shanghai Sigma High-Tech Co., Ltd.
510(k) number
K242908
Product code
FTC
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-19
Date received
2024-09-24
Regulation
878.4630
Classification name
Light, Ultraviolet, Dermatological
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Xing Guo
Address
The W. Wing, 1st Floor., Bldg. #7&The E. Wing, 11th Floor Bldg. #8, #388 Shuanglian Rd., Xujing Town, Qingpu D Shanghai CN

FDA Registration Numbers

Source Documents

510(k) summary PDF

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