Cleared Traditional

K132838 - NUTRA LIGHT BLUE

K132838 is an FDA 510(k) clearance for NUTRA LIGHT BLUE, manufactured by Nutra Luxe MD, LLC. The device is a Class 2 General & Plastic Surgery device with product code OLP cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K132838 · Nutra Luxe MD, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
255d
Days
Class 2
Risk

K132838 is an FDA 510(k) clearance for the NUTRA LIGHT BLUE. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Nutra Luxe MD, LLC (Sparks, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 255 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 Nutra Luxe MD, LLC devices

FDA 510(k) Submission Details - K132838

510(k) Number K132838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2013
Decision Date May 23, 2014
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLP Device Classification - Class 2, Special Controls

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.