# Sofregen Medical, Inc.

- Location (FDA's records): Medford, MA
- FDA decisions: 3 (2017–2024): 3 510(k) clearances
- Names in FDA's records: Sofregen Medical, Inc. (2); Sofregen Medical (1)
- Product codes: MIX (2), OXF (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Bioform Medical, Inc.: 1 (https://510kreport.com/company/bioform-medical)
- Allergan, Inc.: 1 (https://510kreport.com/company/allergan)

## Its most-cited devices
- K180631: Silk Voice (2018), cited by 1

## Recent decisions
- K240919: Silk Voice (SMI-04) (May 3, 2024)
- K180631: Silk Voice (Nov 8, 2018)
- K172545: SERI Contour (Sep 22, 2017)

Source page: https://510kreport.com/company/sofregen-medical