Cleared Traditional

K884241 - STAAR PHACO XL SMALL INCISION SYSTEM

K884241 is an FDA 510(k) clearance for STAAR PHACO XL SMALL INCISION SYSTEM, manufactured by Staar Surgical Co.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K884241

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
Combination Product No
PCCP Authorized No
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.

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 193
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K884241.
SITE PHACO PLUS INFUSION SLEEVE
K892852 · Site Microsurgical Systems, Inc. · Jun 1989
SITE PERISTALTIC CASSETTE
K892911 · Site Microsurgical Systems, Inc. · May 1989
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K890635 · CooperVision, Inc. · May 1989
SITE MACROBORE PHACO NEEDLE
K883099 · Site Microsurgical Systems, Inc. · Sep 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K883199 · Chiron Vision Corp. · Sep 1988
SITE ULTRASONIC I/A PHACO NEEDLE
K882103 · Site Microsurgical Systems, Inc. · Jul 1988