Paragon Vision Sciences
Medical device manufacturer in Gilbert, AZ.
16510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact LensesHQD · Traditional | 05/05/2023SE |
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…HQD · Traditional | 03/16/2018SE |
| K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151…HQD · Traditional | 06/28/2012SE |
| K082799 | HDS Hi 1.54HQD · Traditional | 01/27/2009SE |
| K070637 | Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin Rigid Gas Permeable…HQD · Traditional | 05/01/2007SE |
| K052983 | Fluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable…HQD · Traditional | 02/10/2006SE |
| K013310 | PVS Basic 2; Epic 2HQD · Traditional | 04/25/2002SE |
| K010109 | Fluoroperm 151-OK, Paragon HDS 100-OKMUW · Traditional | 02/28/2001SESU |
| K002845 | Paflufocon C and E Daily Contact LensHQD · Traditional | 12/08/2000SE |
| K993586 | Sportsight GPHQD · Traditional | 05/22/2000SE |
| K000224 | Fluroperm 60-OK, Paragon Hds-OkMUW · Traditional | 04/17/2000SESU |
| K993487 | Paragon Lens VialLRX · Traditional | 12/22/1999SE |
| K993486 | Paragon Lens CarrierLRX · Traditional | 12/22/1999SE |
| K984436 | PVS BasicsHQD · Traditional | 04/21/1999SE |
| K974635 | Paragon Lens CareLRX · Traditional | 02/04/1998SE |
| K940277 | Paflufocon a, B, C & DHQD · Traditional | 05/09/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2516-2023 Class II | Fargo Ortho-K LensManufactured lenses are not covered by existing FDA approval | 06/26/2023Open, Classified |
| Z-2515-2023 Class II | ISee Ortho-K LensManufactured lenses are not covered by existing FDA approval | 06/26/2023Open, Classified |