K-number	K243453
Device name	Philips Lumea IPL
Applicant	Philips Consumer Lifestyle B.V.
Product code	OHT
Device class	Class II
Decision date	Feb 10, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Philips Lumea IPL is an over-the-counter device indicated for removal of unwanted hair in a single user. It is also indicated for permanent reduction in hair regrowth, defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completing a treatment regime.

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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Philips Lumea IPL

Everything you need for a 510(k) submission. Nothing you don't.