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510(k) K851936

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT by Staar Surgical Co. — Product Code HQE

K851936 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT". The FDA issued a decision of Substantially Equivalent on August 20, 1985. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Staar Surgical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1985
Date Received
May 6, 1985
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 Staar Surgical Co.

  • K172375 — MicroSTAAR Injector System Cartridges (September 6, 2017)
  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K090161 — EPIPHANY INJECTION SYSTEM (June 9, 2009)
  • K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K020734 — SURGE-FREE ASPIRATION ADAPTER (May 16, 2002)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K980696 — FOAM TIP INJECTOR (September 11, 1998)
  • K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (December 21, 1995)

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