Cleared Abbreviated

K062930 - LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K062930 · Alcon Research, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
41d
Days
Class 1
Risk

K062930 is an FDA 510(k) clearance for the LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM. Classified as Aberrometer, Ophthalmic (product code NCF), Class I - General Controls.

Submitted by Alcon Research, Ltd. (Orlando, US). The FDA issued a Cleared decision on November 8, 2006 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alcon Research, Ltd. devices

Submission Details

510(k) Number K062930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date November 08, 2006
Days to Decision 41 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NCF Aberrometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.