Cleared Traditional

K031404 - DIGNITY OPHTHALMIC SURGICAL SYSTEM

K031404 is an FDA 510(k) clearance for DIGNITY OPHTHALMIC SURGICAL SYSTEM, manufactured by Phacor Inc., A Santen Company. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K031404 · Phacor Inc., A Santen Company · Ophthalmic device
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May 2003
Decision
17d
Days
Class 2
Risk

K031404 is an FDA 510(k) clearance for the DIGNITY OPHTHALMIC SURGICAL SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Phacor Inc., A Santen Company (San Luis Obispo, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 17 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 Phacor Inc., A Santen Company devices

FDA 510(k) Submission Details - K031404

510(k) Number K031404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date May 22, 2003
Days to Decision 17 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 110d · This submission: 17d
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 188
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K031404.
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