Cleared Traditional

K192418 - Phacoemulsification Needle (Tip) and Irrigation Sleeve

K192418 is an FDA 510(k) clearance for Phacoemulsification Needle (Tip) and Ir..., manufactured by Raico, LLC. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K192418 · Raico, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
266d
Days
Class 2
Risk

K192418 is an FDA 510(k) clearance for the Phacoemulsification Needle (Tip) and Irrigation Sleeve. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Raico, LLC (Westmont, US). The FDA issued a Cleared decision on May 27, 2020 after a review of 266 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.

View all Raico, LLC devices

FDA 510(k) Submission Details - K192418

510(k) Number K192418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date May 27, 2020
Days to Decision 266 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 110d · This submission: 266d
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 K192418.
xPORT S Lens Fragmentation System
K200207 · Carl Zeiss Meditec Cataract Technology, Inc. · Oct 2020
xPORT 304 (miCOR) System Lens Fragmentation System
K200584 · Carl Zeiss Meditec Cataract Technology, Inc. · Jul 2020
Visalis V500, Visalis S500
K193376 · Carl Zeiss Meditec, AG · Jun 2020
LEGION System
K191650 · Alcon Research, LLC · Nov 2019
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
K190875 · D.O.R.C. Dutch Ophthalmic Research Center (International) · Sep 2019
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
K191933 · Johnson & Johnson Surgical Vision, Inc. · Aug 2019