Cleared Special

K041998 - PHACO CHOP NEEDLES

K041998 is an FDA 510(k) clearance for PHACO CHOP NEEDLES, 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 21-day FDA review.

K041998 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
21d
Days
Class 2
Risk

K041998 is an FDA 510(k) clearance for the PHACO CHOP NEEDLES. 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 August 16, 2004 after a review of 21 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 - K041998

510(k) Number K041998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2004
Decision Date August 16, 2004
Days to Decision 21 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
89d faster than avg
Panel avg: 110d · This submission: 21d
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 K041998.
THE AMO OPHTHALMIC SURGICAL SYSTEM
K060366 · Advanced Medical Optics, Inc. · Apr 2006
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
VENTURI PHACO PACK
K033653 · Bausch & Lomb, Inc. · Dec 2003
PERFECT CAPSULE
K030957 · Milvella Pty. , Ltd. · Aug 2003
DIGNITY OPHTHALMIC SURGICAL SYSTEM
K031404 · Phacor Inc., A Santen Company · May 2003
K041998 · PHACO CHOP NEEDLES
Download PDF FDA Summary Bausch & Lomb, Inc.