IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)

Alovea Healthcare 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
K252618
Device name
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-08-19
Decision date
2025-11-14
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 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 removing by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model I6 S1, I6 D1 and I6 M1. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. Model I6 S1 adopts single pulse technology, I6 D1 adopts dual pulse technology, and I6 M1 can switch between single pulse and dual pulse. The device is only powered by the external power adapter and its IPL emission activation is by finger switch or auto flash mode. The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.3cm2 that is suitable for multiple hair removal areas, such as limbs, armpits, upper lip, back, chest, bikini area. The device contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the sapphire ice cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

Summary parsed at:2026-06-11 04:32:08 UTC

Predicate devices

3

K252618 references 3 predicate/reference devices

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0

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