IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C

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

3

Cited as predicate

9

Device details

FDA 510(k) registration fields

K number
K221002
Device name
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-04-04
Decision date
2022-06-01
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyLegsBikini / BrazilianUnderarm
Primary application
Body
Classification source
AI classified

Indications for Use

IPL Hair Removal Device 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.

Intended Use

IPL Hair Removal Device 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

IPL Hair Removal Device (Model: UI04A, UI04B, UI04C), 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. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience. IPL Hair Removal Device, model: UI04A, UI04B, UI04C have the same indication for use, performance, structure design and operation, the only difference is their enclosure color (UI04A is white, UI04B is mint green and UI04C is deep green).

Summary parsed at:2026-06-11 04:32:27 UTC

Predicate devices

3

K221002 references 3 predicate/reference devices

Cited as predicate

9

9 submissions cite K221002 as a predicate