Cleared Traditional

TROKEL /3 GONIO LASER LENS

K921414 · Ocular Instruments, Inc. · Ophthalmic
Nov 1992
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K921414 is an FDA 510(k) clearance for the TROKEL /3 GONIO 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 November 16, 1992, 237 days after receiving the submission on March 24, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K921414 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1992
Decision Date November 16, 1992
Days to Decision 237 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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