Cleared Traditional

K912902 - PHACOEMULSIFICATION SYSTEM FOR OPHTHALM...

K912902 is the FDA 510(k) clearance for PHACOEMULSIFICATION SYSTEM FOR OPHTHALM... by Site Microsurgical Systems, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K912902 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Dec 1991
Decision
168d
Days
Class 2
Risk

K912902 is an FDA 510(k) clearance for the PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on December 17, 1991 after a review of 168 days - an extended review cycle.

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 Site Microsurgical Systems, Inc. devices

Submission Details

510(k) Number K912902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1991
Decision Date December 17, 1991
Days to Decision 168 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
58d slower than avg
Panel avg: 110d · This submission: 168d
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 K912902.
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