Product Classification

• Device: intraocular, pressure measuring device
• Regulation Description: Intraocular pressure measuring device.
• Definition: Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: NVB
• Premarket Review: Ophthalmic Devices (DHT1A); Ophthalmic Devices (DHT1A)
• Submission Type: PMA
• Regulation Number: 886.4280
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible