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U.S. Department of Health and Human Services

Product Classification

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Device ophthalmoscope, laser, scanning
Regulation Description Ophthalmoscope.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMYC
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
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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