Cleared Special

K033653 - VENTURI PHACO PACK

K033653 is an FDA 510(k) clearance for VENTURI PHACO PACK, manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Special 510(k) pathway after a 26-day FDA review.

K033653 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
26d
Days
Class 2
Risk

K033653 is an FDA 510(k) clearance for the VENTURI PHACO PACK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 17, 2003 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033653

510(k) Number K033653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date December 17, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 271
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K033653.
MICROPULSE PHACOEMULSIFICATION SYSTEM
K051186 · Trillium Medical, Inc. · Aug 2005
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
K050648 · Advanced Medical Optics, Inc. · Apr 2005
PHACO CHOP NEEDLES
K041998 · Bausch & Lomb, Inc. · Aug 2004
PERFECT CAPSULE
K030957 · Milvella Pty. , Ltd. · Aug 2003
DIGNITY OPHTHALMIC SURGICAL SYSTEM
K031404 · Phacor Inc., A Santen Company · May 2003
BENJAMIN ENVOY PHACO HANDPIECE
K022833 · Benjamin Biomedical, Inc. · Sep 2002
K033653 · VENTURI PHACO PACK
Download PDF FDA Summary Bausch & Lomb, Inc.