IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02

Shenzhen Jizhimei 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

3

Device details

FDA 510(k) registration fields

K number
K230360
Device name
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-02-10
Decision date
2023-04-10
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyFace
Primary application
Body
Classification source
AI classified

Indications for Use

The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Intended Use

The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Device Description

IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL). The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is powered by an external power adapter and its IPL emission activation is by finger switch. It has an irreplaceable light exit that can cover an area of 3.6cm2 suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, preventing light emission if not in full contact with the skin. Additionally, it features a cooling function activated throughout the hair removal process to cool down the treatment area and enhance user experience.

Summary parsed at:2026-06-11 04:38:57 UTC

Predicate devices

2

K230360 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K230360 as a predicate