Cleared Traditional

K942180 - KEELER MULTILASE 3000 (FDA 510(k) Clearance)

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

K942180 · Keeler Instruments, Inc. · Ophthalmic device
Nov 1994
Decision
202d
Days
Class 2
Risk

K942180 is an FDA 510(k) clearance for the KEELER MULTILASE 3000. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 202 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.

Submission Details

510(k) Number K942180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1994
Decision Date November 22, 1994
Days to Decision 202 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 156d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
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.