510(k) K251255
K251255 is an FDA 510(k) premarket notification submitted by Lymphatech, Inc. for the device "LymphaTech Mobile 3D Measuring Tool". The FDA issued a decision of Substantially Equivalent on July 22, 2025. The device falls under product code SFG (Camera, Surgical, Measurement), a Class I device regulated under 21 CFR 878.4160.
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.