Bd-3000 Microkeratome System, Model K-3000 Microkeratome

• • Terminated Z-0634-03 FDA Unclassified (pre-2012) ·initiated 24 Jan 2003

  Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.

510(k) Number

K022637 ↗

FDA Product Code

HMY

Device Class

Class I

Regulation

21 CFR Part 886.4370

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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