Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
The SmoothCool HR System is an Intense Pulsed Light (IPL) system used for hair removal (Permanent hair reduction) in the area of dermatology. The system consists of a console containing the power unit and control electronics with control and display panel including software. Applicators/hand pieces are connected to the system in order to generate light energy for treatment in the waveband 420-950 nm. Four different hand pieces are attached with the system.
Summary parsed at:2026-06-01 05:32:20 UTC
SmoothCool HR System
K223685 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K223685 as a predicate
