Cleared Traditional

K984143 - FIBRA-SONICS PHACO III OR IIIP FRAGMENT...

K984143 is an FDA 510(k) clearance for FIBRA-SONICS PHACO III OR IIIP FRAGMENT..., manufactured by Fibra Sonics, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K984143 · Fibra Sonics, Inc. · Ophthalmic device
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Feb 1999
Decision
90d
Days
Class 2
Risk

K984143 is an FDA 510(k) clearance for the FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Fibra Sonics, Inc. (Chicago, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 90 days - within the typical 510(k) review window.

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 Fibra Sonics, Inc. devices

FDA 510(k) Submission Details - K984143

510(k) Number K984143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1998
Decision Date February 16, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 113
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