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U.S. Department of Health and Human Services

Product Classification

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Device lenses, soft contact, daily wear
Regulation Description Soft (hydrophilic) contact lens.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLPL
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5925
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
Accredited Persons
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