Cleared Traditional

STAURENGHI WIDE FIELD SCANNING LASER LENS

K014170 · Ocular Instruments, Inc. · Ophthalmic
Mar 2002
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K014170 is an FDA 510(k) clearance for the STAURENGHI WIDE FIELD SCANNING LASER LENS, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 4, 2002, 74 days after receiving the submission on December 20, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K014170 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2001
Decision Date March 04, 2002
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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