Cleared Traditional

K052814 - LUMINA 1600, 3300 AND 6600 SYSTEMS

K052814 is an FDA 510(k) clearance for LUMINA 1600, manufactured by Usa Laser Biotech, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K052814 · Usa Laser Biotech, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
57d
Days
Class 2
Risk

K052814 is an FDA 510(k) clearance for the LUMINA 1600, 3300 AND 6600 SYSTEMS. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Usa Laser Biotech, Inc. (Houston, US). The FDA issued a Cleared decision on November 30, 2005 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K052814

510(k) Number K052814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date November 30, 2005
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 116d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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