Cleared Traditional

K050518 - REPROCESSED PHACOEMUISIFICATION TIPS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050518 · Alliance Medical, Inc. · Ophthalmic device
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Sep 2005
Decision
206d
Days
Class 2
Risk

K050518 is an FDA 510(k) clearance for the REPROCESSED PHACOEMUISIFICATION TIPS. Classified as Needle, Phacoemulsification, Reprocessed (product code NKX), Class II - Special Controls.

Submitted by Alliance Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on September 23, 2005 after a review of 206 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.

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Submission Details

510(k) Number K050518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2005
Decision Date September 23, 2005
Days to Decision 206 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
96d slower than avg
Panel avg: 110d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKX Needle, Phacoemulsification, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
Definition Needle For Phacoemulsification Device To Remove Cataractous Lens. Same As Needle For Main Phacoemulsification Device And Un-reprocessed Needle With Product Code Hqc, Except This Is A "reprocessed" Needle. The Phacoemulsification Device Is Not Reprocessed, Just The Needle. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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.