Cleared Traditional

ZIESS ENDOPROBE

K922735 · Carl Zeiss, Inc. · Ophthalmic
Jul 1992
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K922735 is an FDA 510(k) clearance for the ZIESS ENDOPROBE, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by Carl Zeiss, Inc. (Princeton, US). The FDA issued a Cleared decision on July 9, 1992, 31 days after receiving the submission on June 8, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number K922735 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1992
Decision Date July 09, 1992
Days to Decision 31 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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