Manufacturer
Shenzhen Jizhimei Technology Co., Ltd.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
Product code
OHT
21 CFR 878.4810
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
2Hand-held IPL device (JOVS Hair Removal Device)
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K230360 references 2 predicate/reference devices
Cited as predicate
3IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
3 submissions cite K230360 as a predicate