Manufacturer
Wuhan Lotuxs Technology Co., Ltd.Diode Laser Hair Removal
Wuhan Lotuxs Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code OHT· 21 CFR 878.4810
Product code
OHT
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K230090
- Device name
- Diode Laser Hair Removal
- Country / Region
- China(CN)
- Product code
- OHT
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-01-12
- Decision date
- 2023-04-19
- Submission type
- Traditional
- Technology type
- Diode laser(AI inferred)
- Clinical applications
- BodyLegsBikini / BrazilianUnderarm
- Primary application
- Body
- Classification source
- AI classified
Indications for Use
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a 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.
Intended Use
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a 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.
Device Description
The Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810nm 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:2026-06-11 04:38:15 UTC
Predicate devices
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K230090 references 1 predicate/reference device
Cited as predicate
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