Cleared Traditional

K832912 - GELENDER VACUUM FIXATION RING SYS (FDA 510(k) Clearance)

Class I Ophthalmic device.

K832912 · Miami Eye Technology, Inc. · Ophthalmic device
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Jan 1984
Decision
134d
Days
Class 1
Risk

K832912 is an FDA 510(k) clearance for the GELENDER VACUUM FIXATION RING SYS. Classified as Ring, Ophthalmic (flieringa) (product code HNH), Class I - General Controls.

Submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Miami Eye Technology, Inc. devices

Submission Details

510(k) Number K832912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date January 10, 1984
Days to Decision 134 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 110d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNH Ring, Ophthalmic (flieringa)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.