Product Classification

• Device: intraocular pressure lowering implant
• Definition: An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
• Physical State: This device category includes various materials, both biodegradable and non-biodegradable, and includes devices of various designs.
• Technical Method: An intraocular pressure lowering implant uses various methods such as increasing aqueous outflow to reduce intraocular pressure
• Target Area: Eye
• Review Panel: Ophthalmic
• Product Code: OGO
• Premarket Review: Ophthalmic Devices (DHT1A); Ophthalmic Devices (DHT1A)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 10-93 ANSI Z80.27-2014 (R2025)
  American National Standard for Ophthalmics - Implantable Glaucoma Devices

Guidance Document

• Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible