Cleared Traditional

AUTOREF LENSMETER RL-10

K925304 · Canon USA, Inc. · Ophthalmic
Feb 1994
Decision
484d
Days
Class 1
Risk

About This 510(k) Submission

K925304 is an FDA 510(k) clearance for the AUTOREF LENSMETER RL-10, a Refractometer, Ophthalmic (Class I — General Controls, product code HKO), submitted by Canon USA, Inc. (Tokyo 146, JP). The FDA issued a Cleared decision on February 17, 1994, 484 days after receiving the submission on October 21, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number K925304 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1992
Decision Date February 17, 1994
Days to Decision 484 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKO — Refractometer, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1760

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