K242908
- 510(k) number
- K242908
- Device name
- 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. CN
- Product code
- FTC — Light, Ultraviolet, Dermatological
- Decision date
- 2024-12-19
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242908.pdf
Official FDA record: K242908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.