Cleared Special

K082132 - BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK

K082132 is an FDA 510(k) clearance for BAUSCH & LOMB D4600A AIR EXCHANGE LINE 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 30-day FDA review.

K082132 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
30d
Days
Class 2
Risk

K082132 is an FDA 510(k) clearance for the BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on August 28, 2008 after a review of 30 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 - K082132

510(k) Number K082132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2008
Decision Date August 28, 2008
Days to Decision 30 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
80d faster than avg
Panel avg: 110d · This submission: 30d
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 K082132.
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K082132 · BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
Download PDF FDA Summary Bausch & Lomb, Inc.