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510(k) K854868

I/A - VFE SYSTEM II by Mira, Inc. — Product Code HQE

K854868 is an FDA 510(k) premarket notification submitted by Mira, Inc. for the device "I/A - VFE SYSTEM II". The FDA issued a decision of Substantially Equivalent on February 7, 1986. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Mira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1986
Date Received
December 4, 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 Mira, Inc.

  • K951728 — SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE (March 19, 1997)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 1994)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K894248 — CONVERTER SYSTEM (February 27, 1990)
  • K891601 — POWER OPERATED AND CONTROLLED VITREOUS SCISSORS (May 23, 1989)
  • K890448 — LIGHT SOURCE, ENDOSCOP, XENON ARC (May 8, 1989)
  • K863246 — MIRALITE (October 31, 1986)
  • K863591 — ENDOPHOTOCOAGULATION PROBE (October 10, 1986)

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