Cleared Abbreviated

K103023 - UNIT

K103023 is an FDA 510(k) clearance for UNIT, manufactured by Abbott Medical Optics, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Abbreviated 510(k) pathway after a 232-day FDA review.

K103023 · Abbott Medical Optics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
232d
Days
Class 2
Risk

K103023 is an FDA 510(k) clearance for the UNIT, PHACOFRAGMENTATION. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Abbott Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 1, 2011 after a review of 232 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Abbott Medical Optics, Inc. devices

FDA 510(k) Submission Details - K103023

510(k) Number K103023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date June 01, 2011
Days to Decision 232 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 110d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

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 122
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K103023.
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
K191933 · Johnson & Johnson Surgical Vision, Inc. · Aug 2019
xPORT Lens Fragmentation System
K191024 · Carl Zeiss Meditec Cataract Technology, Inc. · Aug 2019
CENTURION VISION SYSTEM
K121555 · Alcon Laboratories, Inc. · Dec 2012
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · Bausch & Lomb, Inc. · Aug 2010
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
K082473 · Bausch & Lomb, Inc. · Jan 2009
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
K082132 · Bausch & Lomb, Inc. · Aug 2008