Cleared Special

VENTURI PHACO PACK (K033653) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033653 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (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.

View all Bausch & Lomb, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 315
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