Cleared Traditional

K021566 - INFINITI

K021566 is the FDA 510(k) clearance for INFINITI by Alcon Laboratories, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K021566 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
50d
Days
Class 2
Risk

K021566 is an FDA 510(k) clearance for the INFINITI. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 50 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 Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K021566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2002
Decision Date July 02, 2002
Days to Decision 50 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
60d faster than avg
Panel avg: 110d · This submission: 50d
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 75
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K021566.
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K063331 · Bausch & Lomb, Inc. · Dec 2006
PHACO CHOP NEEDLES
K041998 · Bausch & Lomb, Inc. · Aug 2004
VENTURI PHACO PACK
K033653 · Bausch & Lomb, Inc. · Dec 2003
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
K981103 · Alcon Laboratories · Jun 1998
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
K974469 · Mentor Corp. · Feb 1998
WELCH ALLYN PHACO ILLUMINATOR
K971750 · Welch Allyn, Inc. · Jun 1997