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U.S. Department of Health and Human Services

Product Classification

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Device laser, ophthalmic
Regulation Description Ophthalmic laser.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQF
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(k)
Regulation Number 886.4390
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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