Identifiers
- 510(k) Number
- K260129 FDA 510(k)
- FDA Product Code
- OLI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5400 FDA 510(k)
- Regulation Number
- 878.5400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lumaflex Panel is a fat reducing low level laser device intended for use in general and plastic surgery applications. It is designed to deliver low-level laser energy for non-invasive fat reduction procedures.
The device is supplied as a reusable system and has received FDA 510(k) clearance under product code OLI and regulation number 878.5400. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd. and is intended for use in clinical settings by trained professionals.
Frequently asked questions
What is the Lumaflex Panel used for?
The Lumaflex Panel is intended for use in general and plastic surgery applications to deliver low-level laser energy for non-invasive fat reduction procedures, as stated in its device description.
Is the Lumaflex Panel reusable or single-use?
The Lumaflex Panel is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, as specified in the device description.
What models are included in the Lumaflex Panel product line?
The Lumaflex Panel includes the models ZLD-05, ZLD-05A, and ZLD-05APro, as explicitly listed in the device name field of the authorization data.
How was the Lumaflex Panel cleared for market release?
The Lumaflex Panel received FDA 510(k) clearance under product code OLI and regulation number 878.5400, with a traditional clearance type and a substantially equivalent decision, as documented in the authorization and specifications fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260129 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
- FDA Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Sources (1)
- FDA 510(k) K260129 24 fields · synced Oct 6, 2026