Clearance Summary
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) received FDA 510(k) clearance under submission number K242908, sponsored by Shanghai Sigma High-Tech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-12-19.
- Submission: K242908
- Applicant / Sponsor: Shanghai Sigma High-Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 2024-12-19
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.