Cleared Traditional

OPHTHALMIC SURGICAL SYSTEM

K935223 · Optical Micro Systems, Inc. · Ophthalmic
Mar 1994
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K935223 is an FDA 510(k) clearance for the OPHTHALMIC SURGICAL SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Optical Micro Systems, Inc. (Waterford, US). The FDA issued a Cleared decision on March 14, 1994, 133 days after receiving the submission on November 1, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K935223 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1993
Decision Date March 14, 1994
Days to Decision 133 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

Similar Devices — HQC Unit, Phacofragmentation

All 313
System Sophi
K250501 · This AG · Nov 2025
MICOR 700 with Auto I/A
K243395 · Carl Zeiss Meditec Cataract Technology, Inc. · Aug 2025
MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
K242801 · Carl Zeiss Meditec Cataract Technology, Inc. · Jun 2025
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
K240169 · Bausch and Lomb, Incorporated · Jul 2024
Faros Surgical System
K233398 · Oertli Instrumente AG · Jun 2024
UNITY VCS (8065000296); UNITY CS (8065000297)
K233876 · Alcon Laboratories, Inc. · Jun 2024