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U.S. Department of Health and Human Services

Product Classification

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Device instrument, visual field, laser
Regulation Description Visual field laser instrument.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHPJ
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1360
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
Accredited Persons
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