Diode laser therapy device (VADER)

Beijing Superlaser Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

4

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

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