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U.S. Department of Health and Human Services

Product Classification

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Device laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla
Regulation Description Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLXS
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4392
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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