INFINITI

Unit, Phacofragmentation

ALCON LABORATORIES, INC.

The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Infiniti.

Pre-market Notification Details

• Device ID: K021566
• 510k Number: K021566
• Device Name: INFINITI
• Classification: Unit, Phacofragmentation
• Applicant: ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099
• Contact: Michael Buenger
• Correspondent: Michael Buenger; ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099
• Product Code: HQC
• Subsequent Product Code: HQR
• Subsequent Product Code: MLZ
• CFR Regulation Number: 886.4670 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-13
• Decision Date: 2002-07-02
• Summary: summary