Cleared Traditional

K251255 - LymphaTech Mobile 3D Measuring Tool (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K251255 · Lymphatech, Inc. · General & Plastic Surgery device
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Jul 2025
Decision
90d
Days
Class 1
Risk

K251255 is an FDA 510(k) clearance for the LymphaTech Mobile 3D Measuring Tool. Classified as Camera, Surgical, Measurement (product code SFG), Class I - General Controls.

Submitted by Lymphatech, Inc. (Atlanta, US). The FDA issued a Cleared decision on July 22, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lymphatech, Inc. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 114d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SFG Camera, Surgical, Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Powers Regulatory Consulting
Grace Powers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.