# K253754: Philips Lumea IPL

- Pathway: 510(k) (Special)
- Applicant: Philips Consumer Lifestyle B.V.
- Decided: Dec 23, 2025 after 28 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K243453 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243453: Philips Lumea IPL, Philips Consumer Lifestyle B.V. (2025) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253754
Methodology: https://510kreport.com/methodology