Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )— 510(k) K260129

Name: FDA 510(k) clearance K260129
Creator: U.S. Food and Drug Administration
Published: 2026-04-15

Substantially Equivalent

Shenzhen Kaiyan Medical Equipment Co., Ltd.

FDA 510(k) clearance K260129 for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ), Substantially Equivalent on 2026-04-15. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
Product code: Code OLI
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2026-01-16
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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