Cleared Traditional

TBD, LENS MEASURING DEVICE

K912134 · Alcon Laboratories · Ophthalmic
Jul 1991
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K912134 is an FDA 510(k) clearance for the TBD, LENS MEASURING DEVICE, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on July 25, 1991, 72 days after receiving the submission on May 14, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K912134 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1991
Decision Date July 25, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HRJ — Table, Instrument, Powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4855