Product Classification

• Device: guide and positioner, ophthalmic drug delivery device
• Regulation Description: Intraocular lens guide.
• Definition: To provide a guide and/or positioner for filling of a drug delivery device.
• Physical State: a guide and/or positioner for filling of a drug delivery device
• Technical Method: To provide a guide and/or positioner for filling of a drug delivery device
• Target Area: eye
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: QQQ
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: Contact ODE
• Regulation Number: 886.4300
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible