Benchmed logo
Benchmed

IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002

Dongguan Lide Electric Appliance Co., Ltd.

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

Product code OHT· 21 CFR 878.4810

View Summary PDF

Company

Dongguan Lide Electric Appliance Co., Ltd.
China (CN)

Product code

OHT
21 CFR 878.4810

Predicate devices

2
View list →

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K232056
Device name
IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
Company
Dongguan Lide Electric Appliance Co., Ltd.
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-07-11
Decision date
2023-10-06
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 (Model: PB1, PB2, PB3, PB4, TM002), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It 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. This product is equipped with a skin sensor to detect appropriate skin contact; if the flash window of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

Summary parsed at:2026-06-11 04:41:14 UTC

Predicate devices

2

K232056 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K232056 as a predicate