Data / Medical devices / United States / Optimax Eyewear Inc
Optimax Eyewear Inc: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
Optimax Eyewear Inc is registered with the FDA (registration 3015393207) in New York, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015393207
- Address
- 954 Lexington Ave, Suite 537, New York, NY, United States, 10021
- Owner or operator
- Optimax Eyewear Inc (10062612)
- Roles
- Complaint file establishment
- First device listed
- July 6, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| December 19, 2016 | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2016. 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.