Synergeyes, Inc.

Synergeyes, Inc. specializes in rigid-gas-permeable hybrid contact lenses designed for daily wear. These lenses combine rigid gas-permeable materials with soft silicone hydrogel layers to provide both optical correction and corneal support. Examples include models like the Synergeyes Casted Buttons and various hybrid designs, such as the SYNERGEYES SIG (Petrafocon A HEM-Larafocon A) and UltraHealth for Keratoconus, which cater to specific vision correction needs.

Synergeyes, Inc. is headquartered in the United States. The company’s devices are classified under FDA Class II, which typically requires premarket notification (510(k)) clearance for new models or modifications. This classification reflects the moderate risk associated with contact lenses, which directly interact with the eye. The devices are also listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, ensuring traceability and regulatory compliance within the U.S. market.

Based on available information, Synergeyes, Inc. devices are not listed in international regulatory registries. Their products are primarily recorded in U.S. databases, such as the FDA’s 510(k) and UDI systems. This suggests their regulatory focus is currently limited to the U.S. market, where their hybrid contact lenses are authorized under FDA oversight.

Synergeyes, Inc. devices fall under FDA Class II classification. This classification is assigned based on the risk posed by the product—contact lenses, particularly those designed for daily wear and specialized conditions like keratoconus, are considered to carry moderate risks. Class II devices typically require a premarket submission (such as a 510(k)) to demonstrate substantial equivalence to a legally marketed predicate device, ensuring safety and performance before commercialization.

Synergeyes, Inc.’s hybrid contact lenses combine a rigid gas-permeable center with a soft silicone hydrogel skirt, offering the optical clarity and corneal support of rigid lenses while improving comfort and wearability. This design is particularly beneficial for conditions like keratoconus, where stability and precise fitting are critical. Examples like the UltraHealth for Keratoconus or the SYNERGEYES SiH with Hydra-PEG incorporate advanced materials (e.g., Petrafocon A or Paflufocon D) to enhance durability, oxygen permeability, and patient compliance.