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U.S. Department of Health and Human Services

Product Classification

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Device laser, microsurgical argon, for uses other than otology, including laryngology & general use in otolarngology
Regulation Description Argon laser for otology, rhinology, and laryngology.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeLMS
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 874.4490
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
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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