||diagnostic low electric field|
||As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision.In addition to other standard methods such as intraoperative imaging and palpation.
||low electromagnetic field
||It utilizes electromagnetic waves to characterize human tissue in real-time. It consists of a console and a disposable hand-piece.
|| General & Plastic Surgery
Office of Device Evaluation
Division of Surgical Devices
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible