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U.S. Department of Health and Human Services

Product Classification

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Device biomicroscope, slit-lamp, ac-powered
Regulation Description AC-powered slitlamp biomicroscope.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHJO
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 886.1850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Slit Lamp Guidance; Final
Third Party Review
Accredited Persons

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