Cleared Traditional

K931855 - LIGHTWRITER

K931855 is an FDA 510(k) clearance for LIGHTWRITER, manufactured by Zygo Corp.. The device is a Class 2 Physical Medicine device with product code ILQ cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K931855 · Zygo Corp. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
392d
Days
Class 2
Risk

K931855 is an FDA 510(k) clearance for the LIGHTWRITER. Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by Zygo Corp. (Portland, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3710 - the FDA physical medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Zygo Corp. devices

FDA 510(k) Submission Details - K931855

510(k) Number K931855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date May 10, 1994
Days to Decision 392 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 115d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILQ Device Classification - Class 2, Special Controls

Product Code ILQ System, Communication, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3710
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 Physical Medicine devices follow this clearance model.