Cleared Traditional

TROKEL /3 GONIO LASER LENS (K921414) - FDA 510(k) Clearance

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

K921414 · Ocular Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
237d
Days
Class 2
Risk

K921414 is an FDA 510(k) clearance for the TROKEL /3 GONIO LASER LENS. Classified as Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (product code LQJ), Class II - Special Controls.

Submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 237 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Ocular Instruments, Inc. devices

Submission Details

510(k) Number K921414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date November 16, 1992
Days to Decision 237 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
127d slower than avg
Panel avg: 110d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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.