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U.S. Department of Health and Human Services

Product Classification

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Device accessories, solution, ultrasonic cleaners for lenses
Regulation Description Soft (hydrophilic) contact lens care products.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLYL
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5928
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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