Light, Lymphedema Reduction, Low Energy

Product Code: NZY

Physical Medicine Medical Laser Products

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.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 890.5500


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as NZY

5480Light, Lymphedema Reduction, Low EnergyInfrared Lamp.

Total Product Life Cycle (TPLC) Devices

5480Light, Lymphedema Reduction, Low EnergyInfrared Lamp.

Pre-market Notifications for NZY

K030295LTU-904 PORTABLE LASER THERAPY UNITRIANCORP PTY LTD

Global Unique Device Identification Database

09352877000135Light, Lymphedema Reduction, Low Energy

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