Cleared Traditional

EPTFE SHEET COVERING FOR OCULAR IMPLANT (K934834) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934834 · Oculo Plastik, Inc. · Ophthalmic device
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May 1994
Decision
209d
Days
Class 2
Risk

K934834 is an FDA 510(k) clearance for the EPTFE SHEET COVERING FOR OCULAR IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Oculo Plastik, Inc. (Montreal, Quebec Canada, CA). The FDA issued a Cleared decision on May 5, 1994 after a review of 209 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - 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 Oculo Plastik, Inc. devices

Submission Details

510(k) Number K934834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date May 05, 1994
Days to Decision 209 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
99d slower than avg
Panel avg: 110d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HPZ Implant, Eye Sphere
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
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.