Manufacturer
Wuhan Lotuxs Technology Co., Ltd.Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
Wuhan Lotuxs Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K232117
- Device name
- Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-07-17
- Decision date
- 2023-11-28
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The device is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Intended Use
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The device is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Device Description
The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
Summary parsed at:2026-06-01 05:33:14 UTC
Predicate devices
2Cited as predicate
1DermRays Revive
1 submission cite K232117 as a predicate
