K251255 is an FDA 510(k) clearance for the LymphaTech Mobile 3D Measuring Tool. This device is classified as a Camera, Surgical, Measurement (Class I - General Controls, product code SFG).
Submitted by Lymphatech, Inc. (Atlanta, US). The FDA issued a Cleared decision on July 22, 2025, 90 days after receiving the submission on April 23, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160. 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..
| 510(k) Number | K251255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2025 |
| Decision Date | July 22, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | SFG - Camera, Surgical, Measurement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |
| Definition | 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. |