# Gelflex Laboratories

- Location (FDA's records): Perth, Western, Wa, AU
- FDA decisions: 4 (1996–2018): 4 510(k) clearances
- Product codes: LPL (4)
- Predicates its devices cite: 3 (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
- Optical Connection, Inc.: 1 (https://510kreport.com/company/optical-connection)
- Alcon Laboratories: 1 (https://510kreport.com/company/alcon-laboratories)
- CooperVision, Inc.: 1 (https://510kreport.com/company/coopervision)

## Recent decisions
- K181558: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens (Sep 6, 2018)
- K030027: Gelflex Synergy Soft Lens Hioxfilcon 49% Water Content Clear or Blue Visitint; Gelflex Hioxifilcon Soft Contact Lens 49% (Apr 1, 2003)
- K962710: Gelflex Delta 55 (Methafilcon a) Hydrophilic Contact Lens (Sep 5, 1996)
- K962711: Gelflex Alpha (Polymacon) Hydrophilic Contact Lens (Sep 5, 1996)

Source page: https://510kreport.com/company/gelflex-laboratories