Cleared Traditional

IRAS PERIMETER

K864012 · Randwal Instrument Co., Inc. · Ophthalmic
Dec 1986
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K864012 is an FDA 510(k) clearance for the IRAS PERIMETER, a Instrument, Visual Field, Laser (Class II — Special Controls, product code HPJ), submitted by Randwal Instrument Co., Inc. (Southbridge, US). The FDA issued a Cleared decision on December 12, 1986, 58 days after receiving the submission on October 15, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1360.

Submission Details

510(k) Number K864012 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1986
Decision Date December 12, 1986
Days to Decision 58 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