Manufacturer
Home Well Trading, Ltd.Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Company
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K181121
- Device name
- Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
- Company
- Home Well Trading, Ltd.
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-04-30
- Decision date
- 2018-06-28
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- FaceBody
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The Beurer IPL 5500 device is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The Beurer IPL 5500 device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Intended Use
The Beurer IPL 5500 device is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The Beurer IPL 5500 device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Device Description
The Beurer IPL 5500 device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Beurer IPL 5500 device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Beurer IPL 5500 device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the Beurer IPL 5500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the Beurer IPL 5500 device will not trigger a pulse.
Summary parsed at:2026-06-11 04:24:27 UTC
Predicate devices
3Cited as predicate
1Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
1 submission cite K181121 as a predicate
