Modulight Oyj

Modulight Oyj specializes in ophthalmic diode laser systems. These devices are engineered for precision eye treatments, such as retinal photocoagulation and other laser-based ocular therapies. The company’s portfolio includes systems like the Modulight ML6710i Laser and the ML-SLA, which are designed for controlled and targeted interventions in ophthalmology.

Modulight Oyj is headquartered in the United States. The company’s location in the US aligns with its regulatory focus on FDA compliance for its ophthalmic laser systems.

Modulight Oyj’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class III devices, which require strict regulatory oversight due to their higher risk profile.

Modulight Oyj’s ophthalmic diode laser systems fall under FDA Class III classification. This classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices require pre-market approval (PMA) or a 510(k) clearance, reflecting their critical role in medical procedures.