IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

Shenzhen Semlamp Intelligent 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

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K221246
Device name
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-05-02
Decision date
2022-07-07
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyFace
Primary application
Body
Classification source
AI classified

Indications for Use

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

Intended Use

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

Device Description

The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. 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. The device mainly contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. The IPL Hair Removal includes SL-B080, SL-B126, and SL-B136 three models. The difference of all models is mainly the exception of appearance and number of buttons which do not affect the intended use. For model SL-B080, it consists of an IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglasses and replacement lampshade in addition to the IPL beauty device main body and adapter. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button. For model SL-B126 and SL-B136, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglasses in addition to the IPL beauty device main body and adapter. The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device), Auto/Manual button and Flash button.

Summary parsed at:2026-06-11 04:32:43 UTC

Predicate devices

2

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