Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. specializes in wound hydrogel dressings, particularly non-antimicrobial sealants for ocular and soft tissue applications. Their primary focus is on products like ReSure Sealant, which is designed to aid in wound closure and protection during surgical procedures. Additionally, they produce an ocular force gauge used clinically to measure intraocular pressure or tissue resistance.

Ocular Therapeutix, Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as its devices are authorised through the FDA’s processes.

Ocular Therapeutix, Inc.’s devices are listed in the FDA’s regulatory databases, including the 510(k) premarket notification program for some products like ReSure Sealant, the Premarket Approval (PMA) pathway for others, and the Unique Device Identifier (UDI) system. These listings reflect the device’s classification and the authorisation pathway used.

Ocular Therapeutix, Inc.’s devices fall into two primary FDA classifications: Class II and Class III. Class II devices, such as certain variants of ReSure Sealant, generally pose moderate risk and require special controls beyond general controls. Class III devices, like the ocular force gauge or specific ReSure Sealant variants, are higher risk and require Premarket Approval (PMA) due to insufficient data to ensure safety and effectiveness through less stringent pathways.