Data / Medical devices / United States / Acucon
Acucon: FDA-registered device maker in Sarasota, FL, United States, 2 510(k) clearances
Acucon is registered with the FDA (registration 3005184723) in Sarasota, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 18, 2005. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005184723
- Address
- 7455 16th Street E Suite 108, Sarasota, FL, United States, 34243
- Owner or operator
- ACUCON, LLC (10086820)
- Roles
- Manufacturer
- First device listed
- December 14, 2022
- Registered through
- 2026
- Brand names listed
- EXTREME H2O 54%, EXTREME H2O 59%
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2005 | K051430 | EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) | LPL | Substantially Equivalent | Hydrogel Vision Corporation | accessdata.fda.gov |
| February 2, 2005 | K040303 | 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS | LPL | Substantially Equivalent | Hydrogel Vision Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 16, 2021 | 87421 | Class II | Terminated | EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hypero | Contact lenses may be mislabeled with the incorrect lens power. | accessdata.fda.gov |
| December 10, 2020 | 86952 | Class II | Terminated | Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-a | One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses | accessdata.fda.gov |
Compare with other makers
Updated July 18, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.