K-numberK250413
Device nameAglaia LED Beauty Device (BP-D2309)
ApplicantShenzhen Perfect Idea Technology Limited
Product codeOHS
Device classClass II
Decision dateMar 18, 2025
DecisionSubstantially Equivalent
Regulation878.4810
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The Aglaia LED Beauty Device (BP-D2309) is a Class II LED-based medical device that emits red and infrared light to treat full-face wrinkles and blue light to treat mild to moderate acne. It is cleared for over-the-counter 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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