FDA records / IPL & laser hair removal
Is Philips Lumea IPL FDA cleared?
Yes — the FDA record names Philips Lumea IPL.
The model name is matched to the linked record below. Clearance is specific to the device and stated use; it is not a performance ranking.
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. What clearance means
Follow the FDA record.
K243453 · View FDA record
- Device name in the FDA record
- Philips Lumea IPL
- Applicant
- Philips Consumer Lifestyle B.V.
- Decision date
- 2025-02-10
- Product code
- OHT: Light Based Over-The-Counter Hair Removal
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.