About This 510(k) Submission
K242908 is an FDA 510(k) clearance for the UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG), a Light, Ultraviolet, Dermatological (Class II — Special Controls, product code FTC), submitted by Shanghai Sigma High-Tech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 19, 2024, 86 days after receiving the submission on September 24, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.