Cleared Traditional

PHACO NEEDLES AND TIPS

K943672 · Microsurgical Technology, Inc. · Ophthalmic
Oct 1994
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K943672 is an FDA 510(k) clearance for the PHACO NEEDLES AND TIPS, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on October 13, 1994, 79 days after receiving the submission on July 26, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K943672 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1994
Decision Date October 13, 1994
Days to Decision 79 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