Cleared Traditional

K974719 - PHACOPAK

K974719 is an FDA 510(k) clearance for PHACOPAK, manufactured by Paradigm Medical Industries, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K974719 · Paradigm Medical Industries, Inc. · Ophthalmic device
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Jan 1998
Decision
33d
Days
Class 2
Risk

K974719 is an FDA 510(k) clearance for the PHACOPAK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Paradigm Medical Industries, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 20, 1998 after a review of 33 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 Paradigm Medical Industries, Inc. devices

FDA 510(k) Submission Details - K974719

510(k) Number K974719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1997
Decision Date January 20, 1998
Days to Decision 33 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
77d faster than avg
Panel avg: 110d · This submission: 33d
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 160
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