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FDA product code NZY

Light, Lymphedema Reduction, Low Energy

Physical MedicineClass 221 CFR 890.5500
US regulatory classifications
US Product Code (FDA)
NZY
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 890.5500
Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.

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About this record

Light, Lymphedema Reduction, Low Energy is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.