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U.S. Department of Health and Human Services

Product Classification

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Device microscope, specular
Regulation Description AC-powered slitlamp biomicroscope.
Definition Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNQE
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1850
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
Accredited Persons