Product code NZY

Device name

Light, Lymphedema Reduction, Low Energy

Medical specialty

Physical Medicine

Device class

2

Regulation number

890.5500

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset