Manufacturer
Shenzhen Gsd Tech Co., Ltd.Light based hair removal device
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K180383
- Device name
- Light based hair removal device
- Company
- Shenzhen Gsd Tech Co., Ltd.
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-02-12
- Decision date
- 2018-05-11
- Submission type
- Traditional
- Technology type
- IPL(AI inferred)
- Clinical applications
- UnderarmFaceLegsOther
- Primary application
- Other
- Classification source
- AI classified
Indications for Use
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
Intended Use
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
Device Description
The Light based hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.
Summary parsed at:2026-06-11 04:24:18 UTC
Predicate devices
2Cited as predicate
1Light Based Hair Removal Device GP592
1 submission cite K180383 as a predicate