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U.S. Department of Health and Human Services

Product Classification

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Device laser, neodymium:yag, pulmonary surgery
Regulation Description Ear, nose, and throat microsurgical carbon dioxide laser.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Anesthesiology
Product CodeLLO
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 874.4500
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
Third Party Review
Accredited Persons

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