Data / Medical devices / United States / Specialeyes LLC
Specialeyes LLC: FDA-registered device maker in Sarasota, FL, United States, 4 510(k) clearances
Specialeyes LLC is registered with the FDA (registration 3004927493) in Sarasota, FL, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 9, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004927493
- Address
- 6447 Parkland DR., Suite 2020, Sarasota, FL, United States, 34243
- Owner or operator
- SPECIALEYES LLC (9068738)
- Roles
- Complaint file establishment
- First device listed
- July 6, 2011
- Registered through
- 2026
- Brand names listed
- Lenses, soft contact, daily wear, SpecialEyes 49, SpecialEyes 54, SpecialEyes 54 Multifocal, SpecialEyes 59
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 9, 2010 | K101122 | BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS | LPL | Substantially Equivalent | Benz Research and Development Corp. | accessdata.fda.gov |
| August 6, 2007 | K062854 | BENZ-G 4X HIOXIFILCON D | LPL | Substantially Equivalent | Benz Research and Development Corp. | accessdata.fda.gov |
| December 22, 1998 | K983773 | BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | LPL | Substantially Equivalent | Benz Research and Development Corp. | accessdata.fda.gov |
| March 7, 1997 | K964528 | (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT | LPL | Substantially Equivalent | Benz Research and Development Corp. | accessdata.fda.gov |
Compare with other makers
Updated August 9, 2010. 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.