Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)— 510(k) K240874

Name: FDA 510(k) clearance K240874
Creator: U.S. Food and Drug Administration
Published: 2024-05-28

Substantially Equivalent

Theralaser Medtech (China) Co., Ltd.

FDA 510(k) clearance K240874 for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B), Substantially Equivalent on 2024-05-28. Applicant: Theralaser Medtech (China) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Theralaser Medtech (China) Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2024-03-29
Decision date: 2024-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ingxiang High-Tech Industrial Park Chang, CN

Download summary PDF View on FDA.gov ↗

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K261673 — LED Therapy Device (QLXY-01)2026-09-17
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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.