Vistitome 20-10 Microkeratome

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K014000 ↗

FDA Product Code

HNO

Device Class

Class I

Regulation

21 CFR Part 886.4370

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• EpiGARD

  Class IIb

  CE/MDD

• Modification to Visitome 20-10 Microkeratome

  Class I

  FDA 510(k) K042083 Active Cleared 16 Nov 2004

• Leadfix Bioresorbable Membrance Pin System

  Class II

  FDA 510(k) K974392 Active Cleared 30 Jan 1998

• Diamond Nd:yag Ophthalmic Laser

  Class II

  FDA 510(k) K901636 Active Cleared 22 Jun 1990

• Crystal Focus Emerald Laser Slt Mcx 1.5 Convex Pro

  Class II

  FDA 510(k) K910027 Active Cleared 25 Sep 1991

• B-Scan Opthalmic Ultrasound Imaging System

  Class II

  FDA 510(k) K926251 Active Cleared 14 Sep 1993

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