DeviceClearance

Product code SFG— General, Plastic Surgery

LymphaTech Mobile 3D Measuring Tool

Classification name
Camera, Surgical, Measurement
Device class
Class 1
Regulation
21 CFR 878.4160
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SFG under 21 CFR 878.4160, via openFDA

Market context for product code SFG

FDA has cleared 1 device under product code SFG, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code SFG

Recent clearances under product code SFG

Data sourced from openFDA. This site is unofficial and independent of the FDA.