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U.S. Department of Health and Human Services

Product Classification
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Device tonometer, ac-powered
Regulation Description Tonometer and accessories.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHKX
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.1930
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 Standard
Guidance Document
Third Party Review Not Third Party Eligible
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