Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Paragon Vision Sciences with 16 510(k) clearances and 2 device recalls. The most recent is a device recall dated Jun 26, 2023: ISee Ortho-K Lens.
510(k) clearances: 16
Device recalls: 2
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
120182018Records1vs 2017+1
02019Records0vs 2018−1
020202020Records0vs 2019+0
02021Records0vs 2020+0
020222022Records0vs 2021+0
32023Records3vs 2022+3
020242024Records0vs 2023−3
02025Records0vs 2024+0
020262026 to dateRecords0
Latest Records
Newest first across sources; each opens the record
Jun 26, 2023
ISee Ortho-K LensClass II · Manufactured lenses are not covered by existing FDA approval
Device recalls
Jun 26, 2023
Fargo Ortho-K LensClass II · Manufactured lenses are not covered by existing FDA approval
Paragon Vision SciencesPARAGON VISION SCIENCES, IncParagon Vision Sciences, Inc.
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
