Cleared Traditional

K864301 - SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)

K864301 is an FDA 510(k) clearance for SITE PHACOEMULSIFICATION SYST/OPHTHALMI..., 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 45-day FDA review.

K864301 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Dec 1986
Decision
45d
Days
Class 2
Risk

K864301 is an FDA 510(k) clearance for the SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD). 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 15, 1986 after a review of 45 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Site Microsurgical Systems, Inc. devices

FDA 510(k) Submission Details - K864301

510(k) Number K864301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date December 15, 1986
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 110d · This submission: 45d
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 K864301.
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · CooperVision, Inc. · Jul 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · Site Microsurgical Systems, Inc. · Jun 1987
I/A/KPE TIP
K864726 · Ipax, Inc. · Jan 1987
OPHTHALMIC FITLER MICRO CAPSULE
K863729 · Ipax, Inc. · Oct 1986
US PLUS-PAK(R) SURGICAL SYSTEM
K863209 · Ipax, Inc. · Sep 1986
SITE PHACO DISPOSABLE CASSETTE
K861060 · Site Microsurgical Systems, Inc. · May 1986