Manufacturer
Shenzhen Lifotronic Technology Co., Ltd.Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
Shenzhen Lifotronic Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251076
- Device name
- Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-08
- Decision date
- 2025-07-30
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.
Intended Use
The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.
Device Description
The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual. The wand can be rotated 135 degrees in either direction. There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne. The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.
Summary parsed at:2026-06-01 05:22:49 UTC