Cleared Traditional

LTU-904 PORTABLE LASER THERAPY UNIT (K030295) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030295 · Riancorp Pty, Ltd. · General & Plastic Surgery device
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Dec 2004
Decision
695d
Days
Class 2
Risk

K030295 is an FDA 510(k) clearance for the LTU-904 PORTABLE LASER THERAPY UNIT. Classified as Light, Lymphedema Reduction, Low Energy (product code NZY), Class II - Special Controls.

Submitted by Riancorp Pty, Ltd. (Leesburg, US). The FDA issued a Cleared decision on December 23, 2004 after a review of 695 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Riancorp Pty, Ltd. devices

Submission Details

510(k) Number K030295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2003
Decision Date December 23, 2004
Days to Decision 695 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
580d slower than avg
Panel avg: 115d · This submission: 695d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NZY Light, Lymphedema Reduction, Low Energy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Intended For Use As A Tool As Part Of A Therapy Regime For The Low Level Light Treatment Of Post Mastectomy Lymphedema And Indicated For Use As A Tool As Part Of A Therapy Regime For The Treatment Of Post Mastectomy Lymphedema.
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.