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U.S. Department of Health and Human Services

Product Classification

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Device retinoscope, ac-powered
Regulation Description Retinoscope.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHKL
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 886.1780
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Retinoscope Guidance; Final
Third Party Review
Accredited Persons

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