Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

Shenzhen Fansizhe Science and Technology Co., Ltd.

Country / region:China (CN)Submission type:Special

Product code OHT· 21 CFR 878.4810

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Product code

OHT
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K253881
Device name
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
Country / region
China(CN)
Product code
OHT
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-12-04
Decision date
2025-12-29
Submission type
Special
Technology type
IPL(AI inferred)
Clinical applications
BodyOther
Primary application
Body
Classification source
AI classified

Indications for Use

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

Intended Use

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

Device Description

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) are a small over-the-counter device for the removal 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. Intense Pulsed Light (IPL) System, all models, 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. Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal. All models have single pulse, dual pulse and three pulse functions. The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles. The device is intended to be used for adults aged over 18.

Summary parsed at:2026-06-11 04:33:21 UTC

Predicate devices

2

K253881 references 2 predicate/reference devices

Cited as predicate

0

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