Cleared Traditional

K922595 - MODIFIED SITE MACROBORE PHACO NEEDLE

K922595 is the FDA 510(k) clearance for MODIFIED SITE MACROBORE PHACO NEEDLE by Chiron Vision Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K922595 · Chiron Vision Corp. · Ophthalmic device
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Aug 1992
Decision
90d
Days
Class 2
Risk

K922595 is an FDA 510(k) clearance for the MODIFIED SITE MACROBORE PHACO NEEDLE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Horsham, US). The FDA issued a Cleared decision on August 31, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Chiron Vision Corp. devices

Submission Details

510(k) Number K922595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date August 31, 1992
Days to Decision 90 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 98
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K922595.
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994
AOD4000 DISPOSABLE PAK
K931357 · American Optical Corp. · Jan 1994
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
K921607 · Chiron Vision Corp. · Jun 1992
GEMINI OPHTHALMIC SURGERY SYSTEM
K911808 · Alcon Laboratories · Jun 1991
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
K901686 · Nidek, Inc. · Jun 1990