IPL Hair Removal Device (JM-843, JM-865, JM-638)

Shenzhen Junmei Technology Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241881
Device name
IPL Hair Removal Device (JM-843, JM-865, JM-638)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-28
Decision date
2024-08-29
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyOther
Primary application
Other
Classification source
AI classified

Indications for Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Intended Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Description

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed 3 models with the same IPL technology for hair removal, which is model JM-843, JM-865, JM-638. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 530-1200nm and 500-1200nm. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

Summary parsed at:2026-06-11 04:47:05 UTC

Predicate devices

3

K241881 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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