510(k) K251255

LymphaTech Mobile 3D Measuring Tool by Lymphatech, Inc. — Product Code SFG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 22, 2025
Date Received: April 23, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Camera, Surgical, Measurement
Device Class: Class I
Regulation Number: 878.4160
Review Panel: SU
Submission Type

An adjunctive tool to measure and record a body parts physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy.