PARAGON VISION SCIENCES, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 16
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2515-2023 | Class II | ISee Ortho-K Lens | June 26, 2023 |
| Z-2516-2023 | Class II | Fargo Ortho-K Lens | June 26, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | May 5, 2023 |
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 6 | March 16, 2018 |
| K120996 | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN | June 28, 2012 |
| K082799 | HDS HI 1.54 | January 27, 2009 |
| K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES | May 1, 2007 |
| K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES | February 10, 2006 |
| K013310 | PVS BASIC 2; EPIC 2 | April 25, 2002 |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | February 28, 2001 |
| K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS | December 8, 2000 |
| K993586 | SPORTSIGHT GP | May 22, 2000 |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | April 17, 2000 |
| K993486 | PARAGON LENS CARRIER | December 22, 1999 |
| K993487 | PARAGON LENS VIAL | December 22, 1999 |
| K984436 | PVS BASICS | April 21, 1999 |
| K974635 | PARAGON LENS CARE | February 4, 1998 |
| K940277 | PAFLUFOCON A, B, C & D | May 9, 1994 |