K243453
- 510(k) number
- K243453
- Device name
- Philips Lumea IPL
- Applicant
- Philips Consumer Lifestyle B.V. NL
- Product code
- OHT — Light Based Over-The-Counter Hair Removal
- Decision date
- 2025-02-10
- Date received
- 2024-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.