Cleared Traditional

K143741 - Lipofina Laser System

K143741 is an FDA 510(k) clearance for Lipofina Laser System, manufactured by Yolo Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K143741 · Yolo Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
114d
Days
Class 2
Risk

K143741 is an FDA 510(k) clearance for the Lipofina Laser System. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.

Submitted by Yolo Medical, Inc. (Carpenteria, Bc, CA). The FDA issued a Cleared decision on April 24, 2015 after a review of 114 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - 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.

FDA 510(k) Submission Details - K143741

510(k) Number K143741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2014
Decision Date April 24, 2015
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

OLI Device Classification - Class 2, Special Controls

Product Code OLI Fat Reducing Low Level Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Non-invasive Reduction In Fat Layer For Body Contouring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Rockin' Regulatory, Inc.
Paul Kramsky

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.

Clinical Evidence

ClinicalTrials.gov
NCT02187237 Completed Interventional Industry-sponsored

Safety and Effectiveness of the "YOLO TOUCH" LLLT for Circumference Reduction of the Waistline

A RandomizEd DoUble Blinded Controlled Study to Evaluate the Safety and Effectiveness of the "YOLO TOUCH" Low Level Laser Therapy (LLLT) for Circumference Reduction of he Waistline - REDUCE

50
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Reduction of the Waist Circumference
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Matthew Portz, M.D.
Sponsor Yolo Medical Inc. (industry)
Started 2013-09-01 → Primary completion 2013-11-01 → Completed 2014-01-01
Primary outcome
Reduction of girth measurements for the waistline
Secondary outcome
Complications, device related adverse events during LLLT and device related adverse events post LLLT.
Study completed - no results published. This trial concluded in 2014 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 32
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