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
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
| 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