Cleared Traditional

NEVYAS AUTOPRESS EYE COMPRESSOR

K792255 · Keeler Optical Products , Ltd. · Ophthalmic
Dec 1979
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K792255 is an FDA 510(k) clearance for the NEVYAS AUTOPRESS EYE COMPRESSOR, a Applicator, Ocular Pressure (Class II — Special Controls, product code LCC), submitted by Keeler Optical Products , Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1979, 32 days after receiving the submission on November 9, 1979. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.

Submission Details

510(k) Number K792255 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1979
Decision Date December 11, 1979
Days to Decision 32 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code LCC — Applicator, Ocular Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4610