Cleared Traditional

K913239 - GOLDLENS(TM)
(FDA 510(k) Clearance)

K913239 · Doran Instruments, Inc. · Ophthalmic
Jan 1992
Decision
193d
Days
Class 2
Risk

K913239 is an FDA 510(k) clearance for the GOLDLENS(TM), a Electrode, Corneal (Class II — Special Controls, product code HLZ), submitted by Doran Instruments, Inc. (Littleton, US). The FDA issued a Cleared decision on January 31, 1992, 193 days after receiving the submission on July 22, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1220.

Submission Details

510(k) Number K913239 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1991
Decision Date January 31, 1992
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HLZ — Electrode, Corneal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1220