Cleared Abbreviated

K123474 - AVANT LASER

K123474 is an FDA 510(k) clearance for AVANT LASER, manufactured by Avant Wellness Systems, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Abbreviated 510(k) pathway after a 385-day FDA review.

K123474 · Avant Wellness Systems, LLC · Physical Medicine device
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Dec 2013
Decision
385d
Days
Class 2
Risk

K123474 is an FDA 510(k) clearance for the AVANT LASER. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Avant Wellness Systems, LLC (San Clemente, US). The FDA issued a Cleared decision on December 3, 2013 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K123474

510(k) Number K123474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date December 03, 2013
Days to Decision 385 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 116d · This submission: 385d
Pathway characteristics
Standards-based clearance path.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 215
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