Cleared Traditional

RITCH NYLON SUTURE LASER LENS

K933264 · Ocular Instruments, Inc. · Ophthalmic
Oct 1994
Decision
482d
Days
Class 2
Risk

About This 510(k) Submission

K933264 is an FDA 510(k) clearance for the RITCH NYLON SUTURE 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 October 31, 1994, 482 days after receiving the submission on July 6, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K933264 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1993
Decision Date October 31, 1994
Days to Decision 482 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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