Cleared Traditional

K931866 - SITE'S CD II PHACOEMULSIFICATION HANDPIECE

K931866 is an FDA 510(k) clearance for SITE'S CD II PHACOEMULSIFICATION HANDPIECE, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K931866

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
Combination Product No
PCCP Authorized No
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.

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 195
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K931866.
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994
MODIFIED SITE TXR SYSTEMS
K925828 · Site Microsurgical Systems, Inc. · 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