Paragon Vision Sciences, Inc.
Gilbert, AZ, US
Paragon Vision Sciences, Inc. appears in FDA device records in Gilbert, AZ. FDA records list 16 510(k) clearances between and , 53 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Paragon Vision Sciences, Inc. between 1994 and 2023. The busiest year on record is 1999, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | HQD | Substantially Equivalent | |
| K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG | HQD | Substantially Equivalent | |
| K120996 | FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN | HQD | Substantially Equivalent | |
| K082799 | HDS HI 1.54 | HQD | Substantially Equivalent | |
| K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent | |
| K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent | |
| K013310 | PVS BASIC 2; EPIC 2 | HQD | Substantially Equivalent | |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | MUW | Unknown | |
| K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS | HQD | Substantially Equivalent | |
| K993586 | SPORTSIGHT GP | HQD | Substantially Equivalent | |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | MUW | Unknown | |
| K993487 | PARAGON LENS VIAL | LRX | Substantially Equivalent | |
| K993486 | PARAGON LENS CARRIER | LRX | Substantially Equivalent | |
| K984436 | PVS BASICS | HQD | Substantially Equivalent | |
| K974635 | PARAGON LENS CARE | LRX | Substantially Equivalent | |
| K940277 | PAFLUFOCON A, B, C & D | HQD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013398957 | 3013398957 | Paragon Vision Sciences, Inc. | 2120 W. Guadalupe Rd., Gilbert, AZ 85233 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2516-2023 | Fargo Ortho-K Lens | Manufactured lenses are not covered by existing FDA approval | Class II | Open, Classified | |
| Z-2515-2023 | ISee Ortho-K Lens | Manufactured lenses are not covered by existing FDA approval | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain