Cleared Traditional

Contour Light CL-100 (K202955) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K202955 · Contour Research, LLC · General & Plastic Surgery device
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May 2021
Decision
231d
Days
Class 2
Risk

K202955 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 May 19, 2021 after a review of 231 days - an extended review cycle.

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.

View all Contour Research, LLC devices

Submission Details

510(k) Number K202955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date May 19, 2021
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

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 G. 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 14
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K202955.
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UltraSlim Digital, UltraSmooth Digital
K202361 · Ward Photonics, LLC · Dec 2020
invisa-RED ELITE
K192275 · IR Technology, LLC · Aug 2020
Erchonia Emerald
K192544 · Erchonia Corporation · Jan 2020