IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)

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

1

Device details

FDA 510(k) registration fields

K number
K240969
Device name
IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-04-09
Decision date
2024-05-31
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
FaceBodyOther
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. For model SL-B287 and SL-B329, they consist of IPL beauty device main body and power adapter (12V3A) 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 sunglass. 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, select light intensity level), Flash button (to start flashing) and Ice Cooling button (to select ice cooling mode and switch manual / auto flash mode). For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) 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, sunglass and replacement lampshade. 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.

Summary parsed at:2026-06-11 04:45:41 UTC

Predicate devices

2

K240969 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K240969 as a predicate