Manufacturer
Shenzhen Qiaochengli Technology Co., Ltd.IPL Hair Removal
Shenzhen Qiaochengli Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K211174
- Device name
- IPL Hair Removal
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-04-20
- Decision date
- 2021-09-01
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Intended Use
The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Device Description
IPL HAIR REMOVAL, Model: TFDA06S, a portable device, is a prescription home-use 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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission activation is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 260g, and the size is 185.4 × 68.5 × 41.4mm (H*W*D). The device adopts the international photonic beauty IPL technology. The purpose of the light is to heat the root where the hair grows.
Summary parsed at:2026-06-11 04:27:42 UTC
Predicate devices
2IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
Aimanfun Lumea Comfort
K211174 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K211174 as a predicate
