Cleared Traditional

K973229 - D.O.R.C. HEXON ILLUMINATION SYSTEM

K973229 is an FDA 510(k) clearance for D.O.R.C. HEXON ILLUMINATION SYSTEM, manufactured by Dutch Ophthalmic USA, Inc.. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973229 · Dutch Ophthalmic USA, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Nov 1997
Decision
90d
Days
Class 2
Risk

K973229 is an FDA 510(k) clearance for the D.O.R.C. HEXON ILLUMINATION SYSTEM. Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on November 25, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dutch Ophthalmic USA, Inc. devices

FDA 510(k) Submission Details - K973229

510(k) Number K973229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date November 25, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Ophthalmic devices follow this clearance model.

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