Product Classification

• Device: implant, eye valve
• Regulation Description: Aqueous shunt.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: KYF
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.3920
• Device Class: 2
• 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 Documents

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

• Aqueous Shunts - 510(k) Submissions; Final

Third Party Review

Not Third Party Eligible