Cleared Traditional

FIBEROPTIC ILLUMINATED INSTRUMENTS

K934269 · Visitec Co. · Ophthalmic
May 1994
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K934269 is an FDA 510(k) clearance for the FIBEROPTIC ILLUMINATED INSTRUMENTS, a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on May 17, 1994, 259 days after receiving the submission on August 31, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number K934269 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1993
Decision Date May 17, 1994
Days to Decision 259 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJM — Transilluminator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1945

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