Cleared Traditional

ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

K843966 · American Medical Optics · Ophthalmic
Nov 1984
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K843966 is an FDA 510(k) clearance for the ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by American Medical Optics (Irvine, US). The FDA issued a Cleared decision on November 8, 1984, 28 days after receiving the submission on October 11, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number K843966 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1984
Decision Date November 08, 1984
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQB — Photocoagulator And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4690

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