← Product Code [OLI](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI) · K260129

# Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (K260129)

_Shenzhen Kaiyan Medical Equipment Co., Ltd. · OLI · Apr 15, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K260129

## Device Facts

- **Applicant:** Shenzhen Kaiyan Medical Equipment Co., Ltd.
- **Product Code:** [OLI](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI.md)
- **Decision Date:** Apr 15, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.5400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K260129](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K260129)

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