Cleared Traditional

THE OCUPLOT D

K822415 · Coherent Medical Division · Ophthalmic
Sep 1982
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K822415 is an FDA 510(k) clearance for the THE OCUPLOT D, a Instrument, Visual Field, Laser (Class II — Special Controls, product code HPJ), submitted by Coherent Medical Division (Mchenry, US). The FDA issued a Cleared decision on September 7, 1982, 27 days after receiving the submission on August 11, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1360.

Submission Details

510(k) Number K822415 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1982
Decision Date September 07, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPJ — Instrument, Visual Field, Laser
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1360