Fiberlase 100 Medical Laser Sys/Nd:yag Menorrhagia

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K862444 ↗

FDA Product Code

HHR

Device Class

Class II

Regulation

21 CFR Part 884.4550

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Fiberlase II Nd:YAG Laser for Pulmonary Use

  Class II

  FDA 510(k) K872351 Active Cleared 11 Dec 1987

• Nd:yag Laser Single Use Fiber Delivery System

  Class II

  FDA 510(k) K860063 Active Cleared 5 Feb 1986

• Fiberlase 100 Nd: Yag Medical Laser System

  Class II

  FDA 510(k) K855197 Active Cleared 21 Jan 1986

• Single Use Laser Fiber Delivery System for Nd: Yag

  Class II

  FDA 510(k) K863428 Active Cleared 3 Dec 1986

• ND:YAG Fiberlase 100 Medical Laser System

  Class II

  FDA 510(k) K850509 Active Cleared 8 Apr 1985

• Fiberlase 100 Medical Laser System

  Class II

  FDA 510(k) K852798 Active Cleared 29 Jul 1985

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