Manufacturer
Philips Consumer Lifestyle B.V.Philips Lumea IPL
Philips Consumer Lifestyle B.V.
Country / Region:Netherlands (NL)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K243453
- Device name
- Philips Lumea IPL
- Country / Region
- Netherlands(NL)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-11-07
- Decision date
- 2025-02-10
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
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.
Intended 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.
Summary parsed at:2026-06-11 04:27:15 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1Philips Lumea IPL
1 submission cite K243453 as a predicate