# Ophtec USA, Inc.

- Location (FDA's records): Boca Raton, FL
- FDA decisions: 2 (2001–2003): 2 510(k) clearances
- Names in FDA's records: Ophtec USA, Inc. (1); Ophtec, USA (1)
- Product codes: NCE (1), HNQ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 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
- Stephens Instruments: 1 (https://510kreport.com/company/stephens-instruments)

## Recent decisions
- K030471: Ophtec Enclavation Needle (Apr 17, 2003)
- K011498: Easy Control Micro Inserter, Model ON385 (Jul 9, 2001)

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