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U.S. Department of Health and Human Services

Product Classification

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Device ophthalmoscope, battery-powered
Regulation Description Ophthalmoscope.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHLJ
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 886.1570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Ophthalmoscope Guidance
Third Party Review
Accredited Persons

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