Cleared Traditional

K132833 - ULTRA RENEW PLUS (FDA 510(k) Clearance)

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

K132833 · Accord Media · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jun 2014
Decision
280d
Days
Class 2
Risk

K132833 is an FDA 510(k) clearance for the ULTRA RENEW PLUS. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Accord Media (Los Gatos, US). The FDA issued a Cleared decision on June 17, 2014 after a review of 280 days - an extended review 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: 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 Accord Media devices

Submission Details

510(k) Number K132833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2013
Decision Date June 17, 2014
Days to Decision 280 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 114d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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 Peers - OLP Over-the-counter Powered Light Based Laser For Acne

All 50
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