Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
Device Facts
| Record ID | K260129 |
|---|---|
| Device Name | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product Code | OLI · General, Plastic Surgery |
| Decision Date | Apr 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
