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510(k) K854872

VFI/VFE SYSTEM II by Mira, Inc.

K854872 is an FDA 510(k) premarket notification submitted by Mira, Inc. for the device "VFI/VFE SYSTEM II". The FDA issued a decision of Substantially Equivalent on February 13, 1986. Mira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1986
Date Received
December 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)

FDA data resources