Cleared Traditional

PL 20/20 INFANT VISION TESTER

K883337 · Optimed Technologies, Inc. · Ophthalmic
Oct 1988
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K883337 is an FDA 510(k) clearance for the PL 20/20 INFANT VISION TESTER, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Optimed Technologies, Inc. (Lawrence, US). The FDA issued a Cleared decision on October 31, 1988, 83 days after receiving the submission on August 9, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number K883337 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1988
Decision Date October 31, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HOX — Chart, Visual Acuity
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1150

Similar Devices — HOX Chart, Visual Acuity

All 31
CENTRAL VISION ANALYZER MODEL 1000
K100095 · Vimetrics,Llc. · May 2010
HEINE LAMBDA 100
K944156 · Heine USA , Ltd. · Jan 1995
OCCU-TECH VISION TEST
K881971 · Applied Vision Concepts, Inc. · Nov 1988
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
K882634 · Vistech Consultants, Inc. · Jul 1988
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
K881358 · Neuroscientific Corp. · Jun 1988
MCT 8000 (MULTI-VISION CONTRAST TESTER)
K881059 · Vistech Consultants, Inc. · Apr 1988