Data / Medical devices / United States / OptMed, Inc
OptMed, Inc: FDA-registered device maker in New York, NY, United States, 2 510(k) clearances
OptMed, Inc is registered with the FDA (registration 3013833289) in New York, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013833289
- Address
- 745 Fifth Ave., Suite 500, New York, NY, United States, 10151
- Owner or operator
- OptMed (10058967)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 16, 2025
- Registered through
- 2026
- Brand names listed
- BondEase, TearRepair
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 19, 2025 | K243990 | BondEase 2 Topical Skin Adhesive | MPN | Substantially Equivalent | Optmed, Inc. | accessdata.fda.gov |
| September 27, 2024 | K241916 | TearRepair Liquid Skin Protectant | KMF | Substantially Equivalent | Optmed, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 19, 2025. 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.