Cleared Abbreviated

LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM

K062930 · Alcon Research, Ltd. · Ophthalmic

Nov 2006

Decision

41d

Days

Class 1

Risk

About This 510(k) Submission

K062930 is an FDA 510(k) clearance for the LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM, a Aberrometer, Ophthalmic (Class I — General Controls, product code NCF), submitted by Alcon Research, Ltd. (Orlando, US). The FDA issued a Cleared decision on November 8, 2006, 41 days after receiving the submission on September 28, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number	K062930 FDA.gov
FDA Decision	Cleared 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