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510(k) K911998

MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM by Allergan Medical Optics — Product Code HQE

K911998 is an FDA 510(k) premarket notification submitted by Allergan Medical Optics for the device "MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Allergan Medical Optics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
April 29, 1991
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 Allergan Medical Optics

  • K951462 — AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM (June 15, 1995)
  • K941603 — AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE (July 6, 1994)
  • K930320 — AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR (April 7, 1994)
  • K925254 — AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 (January 7, 1993)
  • K924235 — AMO ELITE (December 23, 1992)
  • K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (June 16, 1989)

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