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U.S. Department of Health and Human Services

Product Classification

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Device blade, keratome, reprocessed
Regulation Description Keratome.
Definition Blade for keratome to make flap in cornea for lasik refractive surgery.Same as previously cleared blade for keratomes, product codes hmy and hno, except this is reprocessed.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeNKY
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 886.4370
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions
Third Party Review Not Third Party Eligible
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