Cleared Traditional

LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (K983277) - FDA 510(k) Clearance

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

K983277 · Cuda Products Co. · General & Plastic Surgery device
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Dec 1998
Decision
90d
Days
Class 2
Risk

K983277 is an FDA 510(k) clearance for the LIGHTSOURCE OR ILLUMINATOR MODEL I-100. Classified as Illuminator, Fiberoptic, Surgical Field (product code HBI), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 90 days - within the typical 510(k) review window.

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 Cuda Products Co. devices

Submission Details

510(k) Number K983277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1998
Decision Date December 16, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBI Illuminator, Fiberoptic, Surgical Field
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.