NZY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Light, Lymphedema Reduction, Low Energy

Device class

Class II (moderate risk)

Regulation

21 CFR 890.5500

Medical specialty

Physical Medicine

FDA definition

Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.

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