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U.S. Department of Health and Human Services

Product Classification
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Device fluid, intraocular
Regulation Description Intraocular fluid.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLWL
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Regulation Number 886.4275
Device Class 3
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
Third Party Review Not Third Party Eligible
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