Cleared Traditional

TWO MIRROR GONIO LENS (K895846) - FDA 510(k) Clearance

Class I Ophthalmic device.

K895846 · Ocular Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
76d
Days
Class 1
Risk

K895846 is an FDA 510(k) clearance for the TWO MIRROR GONIO LENS. Classified as Prism, Gonioscopic (product code HKS), Class I - General Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 18, 1989 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ocular Instruments, Inc. devices

Submission Details

510(k) Number K895846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date December 18, 1989
Days to Decision 76 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 110d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKS Prism, Gonioscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1660
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.