Cleared Traditional

ABRAHAM IRIDECTOMY LENS (YAG LASER)

K862713 · Ocular Instruments, Inc. · Ophthalmic
Aug 1986
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K862713 is an FDA 510(k) clearance for the ABRAHAM IRIDECTOMY LENS (YAG LASER), a Prism, Gonioscopic (Class I — General Controls, product code HKS), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 21, 1986, 36 days after receiving the submission on July 16, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1660.

Submission Details

510(k) Number K862713 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1986
Decision Date August 21, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKS — Prism, Gonioscopic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1660

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