Home / 510(k) Clearances / K984143

510(k) K984143

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM by Fibra Sonics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1999
Date Received
November 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
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)
  • 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)
  • K813389 — ULTRASONIC FRAGMENTOR (February 4, 1982)
  • K812909 — HYGIENTIST; CYCLOSON I & II; RETROFIT (December 14, 1981)
  • K802381 — LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. (December 17, 1980)

Other clearances for product code HQC

  • K250501 — System Sophi (November 14, 2025)
  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062 (June 11, 2025)
  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K233398 — Faros Surgical System (June 27, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
  • K230858 — QUATERA 700 (July 31, 2023)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)