Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

Shenzhen Fansizhe Science and 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

1

Cited as predicate

5

Device details

FDA 510(k) registration fields

K number
K223928
Device name
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-12-30
Decision date
2023-03-28
Submission type
Traditional
Technology type
IPL(AI inferred)
Clinical applications
BodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair. 

Environment of Use: Home use

Patient Population: Adult

Intended Use

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Device Description

Intense Pulsed Light (IPL) System, models: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth based on 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 powered by an external power adapter and its IPL emission activation is by a switch or auto light emission. The system contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In 'Skin Color Recognition mode', the device's skin sensor automatically detects skin tone for protection. If the skin tone is not suitable for treatment, the device must not be used. The device also features cooling care functions to reduce excessive heat generated on the skin during hair removal. The Intense Pulsed Light (IPL) System includes the main unit, an adaptor, and goggles. The device is intended for adults aged over 18.

Summary parsed at:2026-06-11 04:37:24 UTC

Predicate devices

1

K223928 references 1 predicate/reference device

Cited as predicate

5

5 submissions cite K223928 as a predicate