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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 Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Diagnostic and Surgical Devices Branch (DSDB)
Submission Type 510(k)
Regulation Number 886.4392
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance on the Content and Organization of a Premarket Notification for a Medical Laser
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons