Cleared Traditional

STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES

K952259 · Storz Instrument Co. · Ophthalmic
Jun 1995
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K952259 is an FDA 510(k) clearance for the STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on June 14, 1995, 30 days after receiving the submission on May 15, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K952259 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1995
Decision Date June 14, 1995
Days to Decision 30 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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