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U.S. Department of Health and Human Services

Product Classification

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Device lens, contact (orthokeratology)
Regulation Description Rigid gas permeable contact lens.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMUW
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5916
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
Third Party Review Not Third Party Eligible
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