Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )— 510(k) K260129
Substantially EquivalentShenzhen 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.
Summary
Shenzhen Kaiyan Medical Equipment's Lumaflex Panel comes in three models, ZLD-05, ZLD-05A, and ZLD-05APro, filed under product code OLI (Fat Reducing Low Level Laser). The record doesn't say how they differ.
Class II, 21 CFR 878.5400. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shenzhen Kaiyan Medical Equipment filed from Shenzhen, China. The record shows 89 calendar days from receipt to decision (January 16 to April 15, 2026).
Clearance details
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Product code
- Product code OLI
- Device class
- Class 2
- Regulation
- 21 CFR 878.5400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OLI
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