Cleared Traditional

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM

K991284 · Nidek, Inc. · Ophthalmic
Aug 1999
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K991284 is an FDA 510(k) clearance for the ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM, a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on August 6, 1999, 113 days after receiving the submission on April 15, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K991284 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1999
Decision Date August 06, 1999
Days to Decision 113 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MXK — Device, Analysis, Anterior Segment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850