Alcon Vision System

FDA 510(k) K063583 · Alcon

Substantially Equivalent

510(k) numberK063583

Submission

Device name
Alcon Vision System
Applicant
Alcon
Fort Worth, TX, US
Received
November 30, 2006
Decision date
May 9, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HQC – Unit, Phacofragmentation
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4670
Specialty
Ophthalmic

Other 510(k)s with product code HQC

510(k)DeviceApplicantDecision
K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special Bausch and Lomb05/15/2026SE
K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional Bausch and Lomb, Incorporated03/25/2026SE
K250501System SophiHQC · Traditional This AG11/14/2025SE
K243395MICOR 700 with Auto I/AHQC · Traditional Carl Zeiss Meditec Cataract Technology, Inc.08/08/2025SE
K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional Carl Zeiss Meditec Cataract Technology, Inc.06/11/2025SE
K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional Bausch and Lomb, Incorporated07/26/2024SE
K233398Faros Surgical SystemHQC · Traditional Oertli Instrumente AG06/27/2024SE
K233876Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional Alcon Laboratories, Inc.06/21/2024SE
K232084Stellaris Elite vision enhancement systemHQC · Traditional Bausch and Lomb02/26/2024SE
K233902Centurion™ Vision System (Active Sentry™) (8065753057)HQC · Special Alcon Laboratories, Inc.01/10/2024SE

More from Alcon Laboratories, Inc.

510(k)DeviceDecision
K071236Alcon Multi-Purpose SolutionLPN · Traditional 12/12/2007SE
K040231Inteliport Occluding DeviceLZU · Traditional 07/13/2004SE
K031193Soft (Hydrophilic) Contact Lens Care SolutionLPN · Traditional 07/03/2003SE
K981574Opti-Free Express Multi-Purpose SolutionLPN · Traditional 07/06/1998SE

Questions and answers

When was Alcon Vision System cleared by the FDA?

Alcon Vision System (K063583) received a 510(k) decision of Substantially Equivalent on May 9, 2008, 526 days after the submission was received.

What is the product code of K063583?

The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.