Philips Consumer Lifestyle B.V.
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Philips Lumea IPL is an Intense Pulsed Light (IPL) device intended for removal of unwanted hair. The Philips Lumea IPL applies spectrally adjusted light to the user skin, which is absorbed by the melanin and after some applications hair sheds naturally and growth is delayed or inhibited. The Philips Lumea IPL is an Over-the-counter hand-held device powered by a wall mount adapter. It is provided in a non-sterile state and intended to be used by single person for multiple uses in homecare environment.
Summary parsed at:2026-06-11 04:33:08 UTC
Philips Lumea IPL
K253754 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K253754 as a predicate
