Diode Laser Therapy Systems (WLA-02)

Wingderm Electro-Optics , 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

5

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252599
Device name
Diode Laser Therapy Systems (WLA-02)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-08-18
Decision date
2026-02-24
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalVascular treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Diode Laser Therapy Systems is intended for use in dermatological procedures requiring coagulation.
Indications for Use:
Mixed Wavelength Handpiece (755 nm + 808 nm + 1064 nm):
- Temporary hair reduction (Hair-Removal function).
- Treatment of benign vascular and vascular-dependent lesions (Vascular-Lesion function).
Single Wavelength Handpieces (755 nm, 808 nm, or 1064 nm):
- Hair removal and permanent hair reduction in all skin types (Fitzpatrick skin types I-VI).
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 completion of a treatment regimen.

Intended Use

The Diode Laser Therapy Systems is intended for use in dermatological procedures requiring coagulation. Indications for Use: Mixed Wavelength Handpiece (755 nm + 808 nm + 1064 nm): -Temporary hair reduction (Hair-Removal function). -Treatment of benign vascular and vascular-dependent lesions (Vascular-Lesion function). Single Wavelength Handpieces (755 nm, 808 nm, or 1064 nm): -Hair removal and permanent hair reduction in all skin types (Fitzpatrick skin types I-VI). 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 completion of a treatment regimen.

Device Description

The Diode Laser Therapy Systems, Model WLA-02, is a medical device intended for dermatological procedures requiring coagulation. It includes mixed and single wavelength handpieces designed for temporary and permanent hair reduction, as well as the treatment of benign vascular lesions. The system delivers controlled laser energy to target melanin or vascular structures while integrated cooling helps protect surrounding skin tissue. The system comprises: Main Console: Includes power switch, handpiece holder, LCD touch screen, emergency shut-off, hand-grip grab bar, handpiece connector, access door, observation window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain, and cooling fans. Treatment Handpiece: Incorporates laser aperture, laser emission indicator, laser emission system, and handpiece display screen. Foot Switch: Activates laser emission. Embedded Software: Diode Laser Therapy Systems Control Software.

Summary parsed at:2026-06-01 05:18:39 UTC

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