Company · US
Paragon Vision Sciences
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2023. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2023 | K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses Paragon Vision Sciences, Inc. | HQD |
| Mar 16, 2018 | K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paf Paragon Vision Sciences | HQD |
| Jun 28, 2012 | K120996 | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN Paragon Vision Sciences | HQD |
| Jan 27, 2009 | K082799 | HDS HI 1.54 Paragon Vision Sciences | HQD |
| May 1, 2007 | K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES Paragon Vision Sciences | HQD |
| Feb 10, 2006 | K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES Paragon Vision Sciences | HQD |
| Apr 25, 2002 | K013310 | PVS BASIC 2; EPIC 2 Paragon Vision Sciences | HQD |
| Feb 28, 2001 | K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK Paragon Vision Sciences | MUW |
| Dec 8, 2000 | K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS Paragon Vision Sciences | HQD |
| May 22, 2000 | K993586 | SPORTSIGHT GP Paragon Vision Sciences | HQD |
| Apr 17, 2000 | K000224 | FLUROPERM 60-OK, PARAGON HDS-OK Paragon Vision Sciences | MUW |
| Dec 22, 1999 | K993487 | PARAGON LENS VIAL Paragon Vision Sciences | LRX |
| Dec 22, 1999 | K993486 | PARAGON LENS CARRIER Paragon Vision Sciences | LRX |
| Apr 21, 1999 | K984436 | PVS BASICS Paragon Vision Sciences | HQD |
| Feb 4, 1998 | K974635 | PARAGON LENS CARE Paragon Vision Sciences | LRX |
| May 9, 1994 | K940277 | PAFLUFOCON A, B, C & D Paragon Vision Sciences | HQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2023 | PARAGON VISION SCIENCES, Inc Fargo Ortho-K Lens Open, Classified |
NUU | None listed |
| Sep 5, 2023 | PARAGON VISION SCIENCES, Inc ISee Ortho-K Lens Open, Classified |
NUU | None listed |