Cleared Traditional

K072459 - OMNILUX NEW-U

K072459 is an FDA 510(k) clearance for OMNILUX NEW-U, manufactured by Photo Therapeutics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K072459 · Photo Therapeutics, Inc. · General & Plastic Surgery device
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Mar 2008
Decision
185d
Days
Class 2
Risk

K072459 is an FDA 510(k) clearance for the OMNILUX NEW-U. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Photo Therapeutics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 3, 2008 after a review of 185 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 Photo Therapeutics, Inc. devices

FDA 510(k) Submission Details - K072459

510(k) Number K072459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2007
Decision Date March 03, 2008
Days to Decision 185 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
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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.