Cleared Traditional

K931866 - SITE'S CD II PHACOEMULSIFICATION HANDPIECE

K931866 is the FDA 510(k) clearance for SITE'S CD II PHACOEMULSIFICATION HANDPIECE by Site Microsurgical Systems, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K931866 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Nov 1993
Decision
212d
Days
Class 2
Risk

K931866 is an FDA 510(k) clearance for the SITE'S CD II PHACOEMULSIFICATION HANDPIECE. 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 November 12, 1993 after a review of 212 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 K931866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date November 12, 1993
Days to Decision 212 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 110d · This submission: 212d
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 K931866.
P4000 PHACOEMULSIFIER
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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
MODIFIED SITE MACROBORE PHACO NEEDLE
K922595 · Chiron Vision Corp. · Aug 1992
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
K921607 · Chiron Vision Corp. · Jun 1992