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Light, Lymphedema Reduction, Low Energy

FDA product code NZY · 1 cleared devices

Class 2 Physical Medicine
Regulation
21 CFR 890.5500
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-12-23 – 2004-12-23

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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