Ultrasonic Fragmentor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K813389 ↗

FDA Product Code

HQE

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta

  Unclassified

  FDA 510(k) K980930 Active Cleared 22 Sep 1998

• Ultrasonic Lithotriptor 300A

  Class II

  FDA 510(k) K842024 Active Cleared 11 Dec 1984

• Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model Ls-2000

  Class II

  FDA 510(k) K993046 Active Cleared 22 Nov 1999

• Fibra-Sonics Phaco III or Iiip Fragmentation System

  Class II

  FDA 510(k) K984143 Active Cleared 16 Feb 1999

• Phaco Fragmentor Gt-1

  Class II

  FDA 510(k) K834453 Active Cleared 16 Mar 1984

• Lewicky Anterior Chamber Mainten. Sys.

  Class II

  FDA 510(k) K802381 Active Cleared 17 Dec 1980

See all devices from Fibra Sonics, Inc. →