Cleared Traditional

SHIELDS T.C. LASER LENS

K893731 · Ocular Instruments, Inc. · Ophthalmic
Aug 1989
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K893731 is an FDA 510(k) clearance for the SHIELDS T.C. LASER LENS, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 17, 1989, 92 days after receiving the submission on May 17, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K893731 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1989
Decision Date August 17, 1989
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code LQJ — Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390

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