Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

Shenzhen Ulike Smart Electronics 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
K241205
Device name
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-04-30
Decision date
2024-09-09
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
UnderarmFaceLegsOther
Primary application
Other
Classification source
AI classified

Indications for Use

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.

Intended Use

Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and single-person-use device for hair reduction by using 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. This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.

Summary parsed at:2026-06-11 04:46:25 UTC

Predicate devices

2

K241205 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K241205 as a predicate