Product code OHT· 21 CFR 878.4810
Company
Product code
FDA 510(k) registration fields
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.
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.
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
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
1 submission cite K181121 as a predicate
