K-number	K254007
Device name	LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
Applicant	SZ KKS Silicone&Electronic Co., Ltd.
Product code	OHS
Device class	Class II
Decision date	Feb 12, 2026
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The LED Light Therapy Silicone Face Mask (models kks-225, kks-280, kks-281) is an over-the-counter medical device that uses LED light to treat wrinkles and mild to moderate acne. It is a silicone face mask equipped with LED technology for dermatological and aesthetic use.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to Quality Management System Regulation (QMSR) requirements including ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action). Electronic product radiation control provisions (21 CFR Parts 1000-1050) may apply.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

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