Cleared Traditional

LASER IRAS

K853556 · Randwal Instrument Co., Inc. · Ophthalmic
Nov 1985
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K853556 is an FDA 510(k) clearance for the LASER IRAS, 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 November 1, 1985, 67 days after receiving the submission on August 26, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1360.

Submission Details

510(k) Number K853556 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1985
Decision Date November 01, 1985
Days to Decision 67 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