IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
Shenzhen Semlamp Intelligent Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260518
- Device name
- IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2026-02-17
- Decision date
- 2026-04-21
- 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 main differences among models are as follows: Model Group Power Adapter Accessories (besides main unit & adapter) Number of Buttons & Key Functions SL-B301, SL-B300 12V2A Manual shaver, replacement head, sunglasses, pouch. 2 Buttons: • Power button (On/Off & select level), • Mode/Flash button. SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-1, SL-B371-2 12V3A All include: Manual shaver, sunglasses, pouch. Except SL-B330 and SL-B371, other models include replacement head. 3 Buttons: • Power button (On/Off & select light intensity), • Flash button (start flash), • Ice Cooling button (select cooling mode / switch manual/auto flash). SL-B352 24V2A Manual shaver, replacement head, sunglasses, pouch. 3 Buttons: • Power button (On/Off & select level), • SHR Button (short press: On/Off SHR mode, long press: On/Off ice cooling), SL-B352-1, SL-B352-2 24V2A Manual shaver, sunglasses, pouch. (No replacement head). 3 Buttons: • Power button (On/Off & select level), • SHR Button (short press: On/Off SHR mode, long press: On/Off skin tone sensor), • Mode/Flash button. SL-B330-F 24V2A Manual shaver, replacement head, sunglasses, pouch. 3 Buttons: • Power button (On/Off & select light intensity), • Flash button (start flash), • Ice Cooling button (select cooling mode / switch manual/auto flash).
Summary parsed at:2026-06-11 04:25:57 UTC
Predicate devices
3IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
K260518 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260518 as a predicate
