Cleared Traditional

K904183 - SITE PHACOEMULSIFICATION HANDPIECE

K904183 is an FDA 510(k) clearance for SITE 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 84-day FDA review.

K904183 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Dec 1990
Decision
84d
Days
Class 2
Risk

K904183 is an FDA 510(k) clearance for the SITE 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 December 5, 1990 after a review of 84 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 - K904183

510(k) Number K904183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date December 05, 1990
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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 K904183.
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
K912739 · Site Microsurgical Systems, Inc. · Aug 1991
GEMINI OPHTHALMIC SURGERY SYSTEM
K911808 · Alcon Laboratories · Jun 1991
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
K904151 · Site Microsurgical Systems, Inc. · Dec 1990
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
K901686 · Nidek, Inc. · Jun 1990
SITE PHACO PLUS INFUSION SLEEVE
K892852 · Site Microsurgical Systems, Inc. · Jun 1989
SITE PERISTALTIC CASSETTE
K892911 · Site Microsurgical Systems, Inc. · May 1989