Cleared Traditional

K912904 - MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM

K912904 is the FDA 510(k) clearance for MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM by Mentor O & O, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K912904 · Mentor O & O, Inc. · Ophthalmic device
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Jun 1992
Decision
345d
Days
Class 2
Risk

K912904 is an FDA 510(k) clearance for the MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Mentor O & O, Inc. (Norwell, US). The FDA issued a Cleared decision on June 11, 1992 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mentor O & O, Inc. devices

Submission Details

510(k) Number K912904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date June 11, 1992
Days to Decision 345 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 110d · This submission: 345d
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 99
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K912904.
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993
MODIFIED SITE MACROBORE PHACO NEEDLE
K922595 · Chiron Vision Corp. · Aug 1992
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
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K890635 · CooperVision, Inc. · May 1989