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510(k) K140930

VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES by Convida Healthcare & Systems Corporation — Product Code FSY

K140930 is an FDA 510(k) premarket notification submitted by Convida Healthcare & Systems Corporation for the device "VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES". The FDA issued a decision of Substantially Equivalent on June 9, 2014. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Convida Healthcare & Systems Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2014
Date Received
April 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Convida Healthcare & Systems Corporation

  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)
  • K122875 — ORICARE L2700 (December 18, 2012)

FDA data resources