Cleared Traditional

HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM

K960287 · Nidek, Inc. · Ophthalmic
Nov 1996
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K960287 is an FDA 510(k) clearance for the HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on November 5, 1996, 288 days after receiving the submission on January 22, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K960287 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1996
Decision Date November 05, 1996
Days to Decision 288 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