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U.S. Department of Health and Human Services

Product Classification

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Device instrument, vitreous aspiration and cutting, battery-powered
Regulation Description Vitreous aspiration and cutting instrument.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHKP
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4150
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
Guidance Document
Third Party Review
Accredited Persons
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