Cleared Traditional

K926381 - OCUSYSTEM IIE

K926381 is an FDA 510(k) clearance for OCUSYSTEM IIE, manufactured by Surgeon Design. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K926381 · Surgeon Design · Ophthalmic device
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Dec 1993
Decision
349d
Days
Class 2
Risk

K926381 is an FDA 510(k) clearance for the OCUSYSTEM IIE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Surgeon Design (Washington, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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. Elevated predicate reliance profile. 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 Surgeon Design devices

FDA 510(k) Submission Details - K926381

510(k) Number K926381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date December 06, 1993
Days to Decision 349 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 110d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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.

Regulatory Peers - HQC Unit, Phacofragmentation

All 198
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K926381.
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NIDEK CV-12000
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K922595 · Chiron Vision Corp. · Aug 1992