Cleared Traditional

K922409 - ALM ILLUMINATOR SERIES LIGHT SYSTEM

K922409 is an FDA 510(k) clearance for ALM ILLUMINATOR SERIES LIGHT SYSTEM, manufactured by Alm Surgical Equipment, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSQ cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K922409 · Alm Surgical Equipment, Inc. · General & Plastic Surgery device
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Jan 1993
Decision
236d
Days
Class 2
Risk

K922409 is an FDA 510(k) clearance for the ALM ILLUMINATOR SERIES LIGHT SYSTEM. Classified as Light, Surgical, Instrument (product code FSQ), Class II - Special Controls.

Submitted by Alm Surgical Equipment, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 12, 1993 after a review of 236 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Alm Surgical Equipment, Inc. devices

FDA 510(k) Submission Details - K922409

510(k) Number K922409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date January 12, 1993
Days to Decision 236 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
121d slower than avg
Panel avg: 115d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSQ Device Classification - Class 2, Special Controls

Product Code FSQ Light, Surgical, Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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.