| 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 Code | NZY |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
