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Paragon Vision Sciences

United Statesfrom the FDA registration address FDA FEI 3013398957

Paragon Vision Sciences is a medical device manufacturer, with 43 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II and III) and 2 FDA recalls as of 13 Nov 2026.

Devices
43
Registrations
FDA
FDA recalls
22 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 26
  • FDA 510(k) 15
  • FDA PMA 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 35
  • FDA Class III 8
FDA recalls
Identifiers
  • FDA FEI 3013398957

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Paragon Vision Sciences makes

Paragon Vision Sciences manufactures rigid-gas-permeable contact lenses for daily and extended wear, including orthokeratology lenses designed to reshape the cornea overnight. Their portfolio also includes contact lens cases for storage and maintenance. Examples include the Paragon HDS100, Fluoroperm series, and SportSight GP lenses, as well as specialized lenses like the Bi-Lens BillBoard and Optacryl 60.

These devices are regulated under FDA classifications, with most falling under Class II and some under Class III. They are listed in the FDA’s 510(k), PMA, and UDI registries. The company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue43

Newest first, rows 1-43 of 43

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Rows 1-43 of 43

Company details

FDA FEI number
3013398957
Address
2120 W. Guadalupe Rd., Gilbert, AZ, 85233

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Paragon Vision Sciences, initiated on 2023-06-26. By recorded status: 2 ongoing. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 2
  • 2024 0
  • 2025 0
  • 2026 0

  • 2023

    • 26 Jun 2023 Z-2515-2023 Class II Ongoing Manufactured lenses are not covered by existing FDA approval Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, Vietnam.
      Submission number: P870024S043
    • 26 Jun 2023 Z-2516-2023 Class II Ongoing Manufactured lenses are not covered by existing FDA approval Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, Vietnam.
      Submission number: P870024S043

Frequently asked questions

How many devices does Paragon Vision Sciences have in the registry?

The registry currently lists 43 devices for Paragon Vision Sciences. Devices recorded under merged duplicate company entries are counted once.

Which registries list Paragon Vision Sciences's devices?

Among its 43 most recently registered devices, Paragon Vision Sciences has devices listed in FDA 510(k) (15 devices), FDA PMA (2 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Paragon Vision Sciences's devices fall under?

Among its 43 most recently registered devices, the classes recorded for Paragon Vision Sciences's devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Paragon Vision Sciences?

FDA recall records list 2 recalls initiated by Paragon Vision Sciences, the most recent initiated on 26 Jun 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Paragon Vision Sciences in the registry?

The most recently registered devices listed for Paragon Vision Sciences include Paragon HDS100, FSA 52, Fluoroperm 30 and SportSight GP.

Generated automatically from registry data and not verified by a human reviewer.