Manufacturer
Jeisys Medical IncorporatedSmoothCool HR System
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K223685
- Device name
- SmoothCool HR System
- Company
- Jeisys Medical Incorporated
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-12-09
- Decision date
- 2023-01-04
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
Intended Use
The SmoothCool HR System is indicated for hair removal (permanent hair reduction).
Device Description
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
Predicate devices
1SmoothCool HR System
K223685 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K223685 as a predicate