Medical Diode Laser Hair Removal System (MNLT-D1)— 510(k) K250431

Name: FDA 510(k) clearance K250431
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Substantially Equivalent

Shandong Moonlight Electronics Tech Co., Ltd.

FDA 510(k) clearance K250431 for Medical Diode Laser Hair Removal System (MNLT-D1), Substantially Equivalent on 2025-05-12. Applicant: Shandong Moonlight Electronics Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Moonlight Electronics Tech Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-02-14
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weifang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

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K241973 — SmartIPL_NI System2026-09-19
K252723 — Dynamis Pro Family2026-09-19
K261047 — Dental Diode Laser Device (Laser-Pen)2026-09-18
K261673 — LED Therapy Device (QLXY-01)2026-09-17
K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)2026-09-17

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.