Cleared Traditional

K912902 - PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

K912902 is an FDA 510(k) clearance for PHACOEMULSIFICATION SYSTEM FOR OPHTHALM..., 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 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

FDA 510(k) Submission Details - K912902

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
Combination Product No
PCCP Authorized No
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.

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 K912902.
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K915118 · Ipax, Inc. · Dec 1991
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LOOK VISCODISSECTOR
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SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
K912739 · Site Microsurgical Systems, Inc. · Aug 1991