# Alcon Laboratories

- Location (FDA's records): Fort Worth, TX
- FDA decisions: 116 (1976–2026): 90 510(k) clearances and 26 original PMA approvals
- Names in FDA's records: Alcon Laboratories (61); Alcon Laboratories, Inc. (54); Alcon Laboratories, LLC (1)
- Product codes: LPL (22), LPN (17), HQC (8), HQL (7), LPM (6), OOE (5), LZS (4), LRX (4), GEX (4), KYB (3), LZP (3), HNR (2)
- 510(k) review time since 2016: median 44 days, against 99 for FDA's reviews in the same codes and years (22 of 29 faster)
- Predicates its devices cite: 140 (43 its own); citations of its devices by later devices: 108 (43 its own)
- Recalls linked to its devices: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ciba Vision Corporation: 40 (https://510kreport.com/company/ciba-vision)
- Alcon Research, Ltd.: 9 (https://510kreport.com/company/alcon-research)
- Bausch & Lomb, Inc.: 5 (https://510kreport.com/company/bausch-lomb)
- CooperVision, Inc.: 4 (https://510kreport.com/company/coopervision)
- Storz Instrument Co.: 3 (https://510kreport.com/company/storz-instrument)
- Innovative Medical Systems, Inc.: 2 (https://510kreport.com/company/innovative-medical-systems)
- Chiron Intraoptics: 2 (https://510kreport.com/company/chiron-intraoptics)
- Staar Surgical Co.: 2 (https://510kreport.com/company/staar-surgical)

## Firms that cite its devices most
- Alcon Research, Ltd.: 8 (https://510kreport.com/company/alcon-research)
- Ciba Vision Corporation: 5 (https://510kreport.com/company/ciba-vision)
- Alcon Manufacturing, Ltd.: 5 (https://510kreport.com/company/alcon-manufacturing)
- Surgical Instruments Service and Savings, Inc.: 3 (https://510kreport.com/company/surgical-instruments-service-and-savings)
- Dutch Ophthalmic Research Center International BV: 3 (https://510kreport.com/company/dutch-ophthalmic-research-center-international)
- Wesley Jessen Corp.: 3 (https://510kreport.com/company/wesley-jessen)
- Bausch & Lomb, Inc.: 3 (https://510kreport.com/company/bausch-lomb)
- Alcon Universal, Ltd.: 3 (https://510kreport.com/company/alcon-universal)

## Its most-cited devices
- K911808: Gemini Ophthalmic Surgery System (1991), cited by 14
- K021566: Infiniti (2002), cited by 10
- K952213: Alcon Series 20000 Legacy Phacoemulsifier (1995), cited by 6
- P830037: Durasoft (R) 3 for Ext Wear (1984), cited by 5
- K962592: Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser Systems (1996), cited by 4
- K980292: Cataract Liquefracture Device (1998), cited by 4

## Recent decisions
- K254052: DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (Feb 13, 2026)
- K252682: LenSx Laser System (8065000944) (Sep 24, 2025)
- K243896: LenSx Laser System (8065998162) (Apr 28, 2025)
- K243909: Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (Jan 13, 2025)
- K242184: Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (Dec 4, 2024)
- K233876: Unity VCS (8065000296); Unity CS (8065000297) (Jun 21, 2024)
- K233902: Centurion™ Vision System (Active Sentry™) (8065753057) (Jan 10, 2024)
- K233856: Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (Dec 29, 2023)

Source page: https://510kreport.com/company/alcon-laboratories