Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
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
- K251173
- Device name
- Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-16
- Decision date
- 2025-07-14
- 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.
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: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF, 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 only powered by the power adapter and its IPL emission activation is by a switch or auto light emission. The device contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. Models T002AQ, T002AD, T002AF, contain 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 has cooling care functions to reduce excessive heat generated on the skin during hair removal. It includes main unit, an adaptor and goggles, and is intended for use by adults aged over 18.
Summary parsed at:2026-06-11 04:29:39 UTC
Predicate devices
3Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
K251173 references 3 predicate/reference devices
Cited as predicate
1Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
1 submission cite K251173 as a predicate