# A.R.C Laser GmbH

- Location (FDA's records): Nurnberg, DE
- FDA decisions: 10 (2000–2022): 10 510(k) clearances
- Names in FDA's records: A.R.C Laser GmbH (6); A.R.C. Laser AG (3); A.R.C. Laser Corp. (1)
- Product codes: GEX (7), HQC (2), HQE (1)
- 510(k) review time since 2016: median 189 days, against 114 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 14 (3 its own); citations of its devices by later devices: 12 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Storz Instrument Co.: 3 (https://510kreport.com/company/storz-instrument)
- Laserscope: 2 (https://510kreport.com/company/laserscope)
- Photo Medex, Inc.: 1 (https://510kreport.com/company/photo-medex)
- Adler Micromed, Inc.: 1 (https://510kreport.com/company/adler-micromed)
- Alcon Laboratories: 1 (https://510kreport.com/company/alcon-laboratories)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)
- CAO Group, Inc.: 1 (https://510kreport.com/company/cao-group)
- Biolitec, Inc.: 1 (https://510kreport.com/company/biolitec)

## Firms that cite its devices most
- Fotona D.O.O.: 3 (https://510kreport.com/company/fotona-doo)
- Lambda Scientific Spa: 1 (https://510kreport.com/company/lambda-scientific)
- El.En S.P.A.: 1 (https://510kreport.com/company/el-en)
- Lensx Lasers, Inc.: 1 (https://510kreport.com/company/lensx-lasers)
- Lambda S.P.A.: 1 (https://510kreport.com/company/lambda)
- Ceramoptec GmbH: 1 (https://510kreport.com/company/ceramoptec)
- Meridian AG: 1 (https://510kreport.com/company/meridian)

## Its most-cited devices
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810 (2008), cited by 6
- K192272: Wolf445nm (2020), cited by 3
- K993154: Laser Photolysis System, Pharo Ophthalmic Surgery System (2000), cited by 2
- K001511: O-Las Ophthalmic Photodisruptor (2000), cited by 1

## Recent decisions
- K220531: Fox 810, Fox 980 (Sep 1, 2022)
- K192272: Wolf445nm (Mar 17, 2020)
- K170183: Cetus system, Cetus probe (Sep 27, 2017)
- K161403: A.R.C. Laser Surgical Fibers and Probes (Aug 16, 2016)
- K091059: Foxq 980 Laser (Aug 13, 2009)
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810 (Feb 22, 2008)
- K003512: Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack II (Feb 8, 2001)
- K002986: A.R.C. Low Bubble Turbo Needle, Model WE0106.5 (Nov 29, 2000)

Source page: https://510kreport.com/company/arc-laser