Cleared Traditional

K884241 - STAAR PHACO XL SMALL INCISION SYSTEM

K884241 is the FDA 510(k) clearance for STAAR PHACO XL SMALL INCISION SYSTEM by Staar Surgical Co.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K884241 · Staar Surgical Co. · Ophthalmic device
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Feb 1989
Decision
129d
Days
Class 2
Risk

K884241 is an FDA 510(k) clearance for the STAAR PHACO XL SMALL INCISION SYSTEM. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 129 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 Staar Surgical Co. devices

Submission Details

510(k) Number K884241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date February 17, 1989
Days to Decision 129 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 110d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 87
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K884241.
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