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U.S. Department of Health and Human Services

Product Classification

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Device instrument, vitreous aspiration and cutting, battery-powered
Regulation Description Vitreous aspiration and cutting instrument.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHKP
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 886.4150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k))
Third Party Review
Accredited Persons

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