Cleared Traditional

K211272 - ICOONE Laser Med (also referred to as ICOONE Medical laser) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211272 · I-Tech Industries Srl · General & Plastic Surgery device
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Jun 2021
Decision
56d
Days
Class 2
Risk

K211272 is an FDA 510(k) clearance for the ICOONE Laser Med (also referred to as ICOONE Medical laser). Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by I-Tech Industries Srl (Bergamo, IT). The FDA issued a Cleared decision on June 22, 2021 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I-Tech Industries Srl devices

Submission Details

510(k) Number K211272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2021
Decision Date June 22, 2021
Days to Decision 56 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
58d faster than avg
Panel avg: 114d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUV Massager, Vacuum, Light Induced Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended To Temporarily Alter The Appearance Of Cellulite
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Mansour Consulting, LLC
Jay Mansour

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.