Cleared Traditional

VISULINK 900 ARGON

K952894 · Carl Zeiss, Inc. · Ophthalmic
Aug 1995
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K952894 is an FDA 510(k) clearance for the VISULINK 900 ARGON, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on August 14, 1995, 52 days after receiving the submission on June 23, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K952894 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1995
Decision Date August 14, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390