# Amo Manufacturing USA, LLC

- Location (FDA's records): Milpitas, CA
- FDA decisions: 9 (1995–2023): 6 510(k) clearances and 3 original PMA approvals
- Product codes: OOE (5), LZS (3), GEX (1)
- 510(k) review time since 2016: median 83 days, against 99 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Medical Optics, Inc.: 2 (https://510kreport.com/company/abbott-medical-optics)
- Amo Manufacturng USA, LLC: 2 (https://510kreport.com/company/amo-manufacturng-usa)
- Surgical Instrument Engineering AG: 1 (https://510kreport.com/company/surgical-instrument-engineering)

## Firms that cite its devices most
- Alcon Laboratories: 1 (https://510kreport.com/company/alcon-laboratories)
- Johnson & Johnson Surgical Vision, Inc.: 1 (https://510kreport.com/company/johnson-johnson-surgical-vision)
- Amo Manufacturng USA, LLC: 1 (https://510kreport.com/company/amo-manufacturng-usa)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)

## Its most-cited devices
- K141852: Ifs Advanced Femtosecond Laser System (2015), cited by 3
- K182083: Catalys Precision Laser System (2018), cited by 1
- K210701: CATALYS Precision Laser System (2021), cited by 1
- K172002: Catalys Precision Laser System (2017), cited by 1

## Recent decisions
- K223838: Catalys™ Precision Laser System (Apr 12, 2023)
- K220516: CATALYS Precision Laser system (May 17, 2022)
- K210701: CATALYS Precision Laser System (Apr 7, 2021)
- K182083: Catalys Precision Laser System (Nov 9, 2018)
- K172002: Catalys Precision Laser System (Aug 25, 2017)
- K141852: Ifs Advanced Femtosecond Laser System (Jan 6, 2015)
- P990010: Visx Excimer Laser System Model C Star (Nov 19, 1999)
- P930016: Visx Excimer Laser System Models B and C (Mar 27, 1996)

Source page: https://510kreport.com/company/amo-manufacturing-usa