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U.S. Department of Health and Human Services

Product Classification

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Device light, lymphedema reduction, low energy
Regulation Description Infrared lamp.
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.
Physical State Unit is a hand-held battery powered treatment device, is non-thermal and is used in the contact mode.
Technical Method Device is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye
Target Area Arms of women who have been treated for cancer and have developed post mastectomy lymphedema
Regulation Medical Specialty Physical Medicine
Review Panel General & Plastic Surgery
Product CodeNZY
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible