K-number	K250425
Device name	Ultraviolet Phototherapy Device
Applicant	APK Technology Co., Ltd.
Product code	FTC
Device class	Class II
Decision date	Apr 7, 2025
Decision	Substantially Equivalent
Regulation	878.4630

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Ultraviolet Phototherapy Device is an ultraviolet light-emitting medical device intended for localized phototherapeutic treatment of dermatologic conditions including psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma across all skin types (I-VI). It is classified as a Class II device and designated for prescription use.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Ultraviolet Phototherapy Device

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