IVYLASER Diode laser hair removal system (IVY-HR-Alloy)

Ivylaser (Beijing) Technology Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K240611
Device name
IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-03-05
Decision date
2024-06-20
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode (FHR).

Intended Use

The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).

Device Description

The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which is intended for temporary hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other system functions are controlled by a control panel on the main unit.

Summary parsed at:2026-06-01 05:27:53 UTC

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