Product Classification

• Device: oral electronic vision aid
• Regulation Description: Oral electronic vision aid.
• Definition: To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)
• Physical State: headset (camera, glasses), intra-oral electrode array, battery, cable, software package
• Technical Method: Translates images of objects captured by a digital camera into electro-tactile signals that are presented to the user's tongue.
• Target Area: tongue, eyes
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: PIC
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.5905
• Device Class: 2
• 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