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U.S. Department of Health and Human Services

Product Classification

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Device tomography, optical coherence
Regulation Description Ophthalmoscope.
Definition Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Physical State Computerized imaging device consisting of light sources and beam delivery and scanning optics.
Technical Method Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.
Target Area Eye.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeOBO
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible