Manufacturer
Beijing Superlaser Technology Co., Ltd.Diode laser therapy device (VADER)
Beijing Superlaser 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
- K251457
- Device name
- Diode laser therapy device (VADER)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-05-12
- Decision date
- 2025-09-03
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Diode laser therapy device (Model: VADER) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.
Intended Use
The Diode laser therapy device (Model:VADER) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.
Device Description
Diode laser therapy device is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The Diode laser therapy device utilizes a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handle. The emission laser is activated by foot-switch or handle button. The laser light targets on melanin and treats selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells. The Diode laser therapy device has a Treatment Handpiece and 2 removable Treatment of the head. The Treatment of the head can be mounted by means of magnetic attraction.
Summary parsed at:2026-06-01 05:23:17 UTC
Predicate devices
4—
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Not ingested
Diode Laser Therapy Systems
Dermatological Diode Laser Systems
Diode laser Treatment System (K18)
K251457 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251457 as a predicate
