Cleared Special

K041212 - HOUVA 3 PHOTOTHERAPY SYSTEM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041212 · National Biological Corp. · General & Plastic Surgery device
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Jun 2004
Decision
30d
Days
Class 2
Risk

K041212 is an FDA 510(k) clearance for the HOUVA 3 PHOTOTHERAPY SYSTEM. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by National Biological Corp. (Twinsburg, US). The FDA issued a Cleared decision on June 9, 2004 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all National Biological Corp. devices

Submission Details

510(k) Number K041212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date June 09, 2004
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 114d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 271
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