# K242908: UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Sigma High-Tech Co., Ltd.
- Decided: Dec 19, 2024 after 86 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K132643 (2014). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223882: Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02), Shenzhen Honpal Optoelectronic Technology Co., Ltd. (2023) Summary page 5.
- K191571: UV Radiation Treatment System, Xuzhou Yongkang Electronic Science Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema). It is to be used on intact skin only. Patients shall use it at home under the guidance of the physician.

Source page: https://510kreport.com/device/K242908
Methodology: https://510kreport.com/methodology