Product Classification

• Device: camera, ophthalmic, slit-scanning
• Regulation Description: Ophthalmic camera.
• Definition: An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
• Physical State: Slit-scanning cameras consist of an incoherent light source, image forming lens, slit forming optics, scanner, an image sensor, and image reconstruction software.
• Technical Method: The imaging plane is scanned by a rectangular slit of non-coherent light and reflected images of the illuminated areas are sequentially captured by an imaging sensor. An ophthalmic image is reconstructed from individual slit images in software.
• Target Area: Eye and ocular tissues (anterior and posterior segment).
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: QER
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.1120
• Device Class: 2
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc