Manufacturer
Wuhan Lotuxs Technology Co., Ltd.DermRays Revive
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
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K231910
- Device name
- DermRays Revive
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-29
- Decision date
- 2024-01-30
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalSkin tighteningVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
DermRays Revive 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. DermRays Revive is also intended for treatment of wrinkles. DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Intended Use
DermRays Revive 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. DermRays Revive is also intended for treatment of wrinkles. DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Device Description
DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water). Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simultaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs. The device consists of a power adapter, a power cord and a main unit.
Summary parsed at:2026-06-01 05:26:24 UTC
Predicate devices
2—
—
Not ingested
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
K231910 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231910 as a predicate
