# Optomed OY

- Location (FDA's records): Oulu, FI
- FDA decisions: 7 (1993–2018): 7 510(k) clearances
- Names in FDA's records: Optomed OY (5); Optomed Corp. (2)
- Product codes: HKI (5), GEX (1), HQB (1)
- Predicates its devices cite: 10 (4 its own); citations of its devices by later devices: 17 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Welch Allyn, Inc.: 2 (https://510kreport.com/company/welch-allyn)
- Kowa Co., Ltd.: 2 (https://510kreport.com/company/kowa)
- Candela Corp.: 1 (https://510kreport.com/company/candela)
- Candela Laser Corp.: 1 (https://510kreport.com/company/candela-laser)

## Firms that cite its devices most
- Phelcom Technologies: 2 (https://510kreport.com/company/phelcom-technologies)
- Tearscience, Inc.: 1 (https://510kreport.com/company/tearscience)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- Remidio Innovative Solutions Private Limited: 1 (https://510kreport.com/company/remidio-innovative-solutions-private)
- Medimaging Integrated Solutions, Inc. (Miis): 1 (https://510kreport.com/company/medimaging-integrated-solutions-miis)
- Annidis Health Systems Corp.: 1 (https://510kreport.com/company/annidis-health-systems)
- Ai Optics: 1 (https://510kreport.com/company/ai-optics)
- Optomed Oyj: 1 (https://510kreport.com/company/optomed-oyj)

## Its most-cited devices
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 (2013), cited by 4
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (2018), cited by 4
- K110986: Optomed Smartscope M5 EY3 and M5 ES1 (2011), cited by 4
- K990417: Dermacool (1999), cited by 3
- K092056: Optomed Smartscope, Model M3-1 EY1 (2009), cited by 2

## Recent decisions
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (Apr 5, 2018)
- K163021: Haag-Streit Fundus Module 300 (Apr 11, 2017)
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 (Dec 18, 2013)
- K110986: Optomed Smartscope M5 EY3 and M5 ES1 (May 16, 2011)
- K092056: Optomed Smartscope, Model M3-1 EY1 (Oct 1, 2009)
- K990417: Dermacool (Apr 14, 1999)
- K923531: Optoscalpel I Laser System (Nov 12, 1993)

Source page: https://510kreport.com/company/optomed