Cleared Special

K243854 - Contour Light (CL-100) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway.

K243854 · Contour Research, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
424d
Days
Class 2
Risk

K243854 is an FDA 510(k) clearance for the Contour Light (CL-100). 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 Contour Research, LLC (Reno, US). The FDA issued a Cleared decision on February 13, 2026 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Contour Research, LLC devices

Submission Details

510(k) Number K243854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date February 13, 2026
Days to Decision 424 days
Submission Type Special
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
310d slower than avg
Panel avg: 114d · This submission: 424d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Bentley Biomedical Consulting, LLC
Shepard Bentley

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
NCT04451824 Completed Interventional Industry-sponsored

Examination of Circumferential Reduction

Contour Research CL-100 Examination of Circumferential Reduction: A Review of Data Collected From Routine Use of the Device

118
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Overweight or Obesity
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Doug Dreier, BS
Sponsor Contour Research (industry)
Started 2018-09-01 → Primary completion 2018-11-30 → Completed 2018-12-31
Primary outcome
Examination of Circumferential Reduction - Primary Objective
Secondary outcome
Examination of Circumferential Reduction - Secondary Objective
Study completed - no results published. This trial concluded in 2018 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. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 31
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K243854.
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
K260129 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Apr 2026
Erchonia CLX (Model # CFL)
K252574 · Erchonia Corporation · Dec 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
K252786 · Shenzhen Suyzeko Limited. · Dec 2025
Erchonia Zerona® VZ8
K243811 · Erchonia Corporation · Jan 2025
Erchonia Violet ZERONA® Z6 OTC
K231474 · Erchonia Corporation · Jul 2023
Erchonia Zerona Z-Bed
K220519 · Erchonia Corporation · Mar 2022