Cleared Traditional

K192275 - invisa-RED ELITE

K192275 is the FDA 510(k) clearance for invisa-RED ELITE by IR Technology, LLC. It is a Class 2 General & Plastic Surgery device (product code OLI) cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K192275 · IR Technology, LLC · General & Plastic Surgery device
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Aug 2020
Decision
363d
Days
Class 2
Risk

K192275 is an FDA 510(k) clearance for the invisa-RED ELITE. 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 IR Technology, LLC (Woodstock, US). The FDA issued a Cleared decision on August 19, 2020 after a review of 363 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. 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. Elevated predicate reliance profile. 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 IR Technology, LLC devices

Submission Details

510(k) Number K192275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2019
Decision Date August 19, 2020
Days to Decision 363 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
248d slower than avg
Panel avg: 115d · This submission: 363d
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

Vidantis Technologies, Inc.
Thomas A. Namynanik

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
NCT03811093 Completed Interventional Industry-sponsored

Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss

Comparing the Efficacy of a Dual-Frequency Laser-Emitting Device, the "Invisared-RED Elite", With a Sham Device as Therapy for the Loss of Adipose Tissue (Body Fat) and Aesthetics in Overweight Individuals

39
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Obesity; Body Weight; Fat Burn; Cellulite; Abdominal Fat; Adipose Tissue Atrophy
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Thomas A Namynanik, BS
Sponsor IR Technology, LLC (industry)
Started 2019-01-21 → Primary completion 2019-02-09
Primary outcome
Change in Body Fat Percentage
View full study on ClinicalTrials.gov