Cleared Traditional

K020527 - HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030

K020527 is an FDA 510(k) clearance for HORIZON PHACOEMULSIFICATION SYSTEM, manufactured by American Optisurgical, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K020527 · American Optisurgical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
140d
Days
Class 2
Risk

K020527 is an FDA 510(k) clearance for the HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by American Optisurgical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on July 9, 2002 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all American Optisurgical, Inc. devices

FDA 510(k) Submission Details - K020527

510(k) Number K020527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date July 09, 2002
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 163
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K020527.
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K063331 · Bausch & Lomb, Inc. · Dec 2006
PHACO CHOP NEEDLES
K041998 · Bausch & Lomb, Inc. · Aug 2004
VENTURI PHACO PACK
K033653 · Bausch & Lomb, Inc. · Dec 2003
INFINITI
K021566 · Alcon Laboratories, Inc. · Jul 2002
SURGE-FREE ASPIRATION ADAPTER
K020734 · Staar Surgical Co. · May 2002
MOJAVE CATARACT EXTRACTION SYSTEM
K003638 · Allergan, Inc. · Feb 2001