OPHTHALMED LLC

Ophthalmed LLC specializes in laser-related devices for ophthalmic (eye) surgery. Their product line includes bending laser probes and single-mode laser fibers, such as the 20G SMA LASER FIBER (Model LF20, LF25, LF100) and various ophthalmic laser probes. These devices are designed for precision laser applications during surgical procedures, ensuring controlled energy delivery in delicate eye surgeries.

Ophthalmed LLC is headquartered in the United States. Their devices are listed in two key regulatory databases: the EU’s eudamed system (for EU market compliance) and the FDA’s 510(k) registry (for US market clearance). These listings reflect their devices’ regulatory status under respective frameworks, though individual device authorizations depend on their classification and approval processes.

Ophthalmed LLC’s devices fall under Class II and Class IIa classifications in regulatory frameworks. Class II devices typically require special controls beyond general controls to ensure safety and effectiveness, while Class IIa devices are generally considered lower risk but still require validation. These classifications determine the regulatory pathway for authorization, such as pre-market notifications (e.g., FDA 510(k)) or conformity assessments (e.g., EU MDR).

Yes, Ophthalmed LLC’s devices are intended for ophthalmic surgical procedures where precision laser delivery is critical. Their bending laser probes and laser fibers (e.g., 20G/25G SMA configurations) are designed for applications like laser-assisted cataract surgery, corneal reshaping (e.g., LASIK), or retinal treatments, where controlled energy application is essential. The design ensures compatibility with laser systems used in these specialized surgeries.