Cleared Traditional

K040062 - LEVIA PHOTOTHERAPY SYSTEM

K040062 is an FDA 510(k) clearance for LEVIA PHOTOTHERAPY SYSTEM, manufactured by Lerner Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K040062 · Lerner Medical Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
31d
Days
Class 2
Risk

K040062 is an FDA 510(k) clearance for the LEVIA PHOTOTHERAPY SYSTEM. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Lerner Medical Devices, Inc. (Los Angeles, US). The FDA issued a Cleared decision on February 13, 2004 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - 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 Lerner Medical Devices, Inc. devices

FDA 510(k) Submission Details - K040062

510(k) Number K040062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2004
Decision Date February 13, 2004
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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 - FTC Light, Ultraviolet, Dermatological

All 52
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K040062.
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K934808 · National Biological Corp. · Dec 1993