Cleared Traditional

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480

K912112 · Tomey Corporation USA · Ophthalmic
Jun 1991
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K912112 is an FDA 510(k) clearance for the PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on June 17, 1991, 35 days after receiving the submission on May 13, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K912112 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1991
Decision Date June 17, 1991
Days to Decision 35 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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