Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Shenzhen Fansizhe Science and Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Device details
FDA 510(k) registration fields
- K number
- K221569
- Device name
- Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-05-31
- Decision date
- 2022-06-30
- Submission type
- Special
- 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.
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 is 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 Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission. Based on the ice-cool technology, the hair removal device with ice-cold compress functions.
Summary parsed at:2026-06-11 04:33:47 UTC
Predicate devices
2IPL Hair Removal Device
Intense Pulsed Light (IPL) System
K221569 references 2 predicate/reference devices
Cited as predicate
3Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
3 submissions cite K221569 as a predicate