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510(k) K813389

ULTRASONIC FRAGMENTOR by Fibra Sonics, Inc. — Product Code HQE

K813389 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "ULTRASONIC FRAGMENTOR". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Fibra Sonics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
December 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Fibra Sonics, Inc.

  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K984199 — EXONIX (February 17, 1999)
  • K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM (February 16, 1999)
  • K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL (December 14, 1998)
  • K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA (September 22, 1998)
  • K842024 — ULTRASONIC LITHOTRIPTOR 300A (December 11, 1984)
  • K834453 — PHACO FRAGMENTOR GT-1 (March 16, 1984)
  • K812909 — HYGIENTIST; CYCLOSON I & II; RETROFIT (December 14, 1981)
  • K802381 — LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. (December 17, 1980)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)

FDA data resources