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.
Product code OHT· 21 CFR 878.4810
Product code
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
1IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
K223928 references 1 predicate/reference device
Cited as predicate
5IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
5 submissions cite K223928 as a predicate