K-numberK260129
Device nameLumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Product codeOLI
Device classClass II
Decision dateApr 15, 2026
DecisionSubstantially Equivalent
Regulation878.5400
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The Lumaflex Panel (models ZLD-05, ZLD-05A, ZLD-05APro) is an over-the-counter LED light therapy device for aesthetic and therapeutic use. It emits red and near-infrared light wavelengths (630–1064 nm depending on model) to reduce circumference of hips/waist/thighs, treat facial wrinkles, and provide temporary relief of minor muscle and joint pain.

Technological characteristics

The device uses light-emitting diodes (LEDs) in multiple treatment modes with varying wavelengths and intensities. ZLD-05 and ZLD-05A emit 630 nm and 850 nm; ZLD-05APro adds 660 nm, 810 nm, 904 nm, and 1064 nm. The device is powered by a rechargeable battery controller; ZLD-05 and ZLD-05APro offer app-based Bluetooth control, while ZLD-05A uses a single physical button. Treatment times range from 10–30 minutes depending on mode.

Test standards cited

IEC 60601-1 (electrical safety), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser light source equipment), IEC 60601-1-2 (electromagnetic compatibility), and IEC 62471 (photobiological safety of lamps). Software verification and validation followed FDA guidance for medical device software; cybersecurity documentation was created per FDA April 2026 guidance.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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