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510(k) K081698

MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) by Image Stream Medical, Inc. — Product Code FTA

K081698 is an FDA 510(k) premarket notification submitted by Image Stream Medical, Inc. for the device "MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)". The FDA issued a decision of Substantially Equivalent on July 30, 2008. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Image Stream Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2008
Date Received
June 17, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Image Stream Medical, Inc.

  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)

Other clearances for product code FTA

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K142386 — Operating Room Light Handle Adapter (September 29, 2014)
  • K133554 — SURGICAL LIGHT HANDLE COVER (April 8, 2014)
  • K133413 — IDSS SLC (January 7, 2014)
  • K112133 — OASYS SURGICAL LIGHT CONTROLLER (March 1, 2012)
  • K102791 — EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (November 23, 2010)
  • K053321 — LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (January 19, 2006)
  • K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX (August 11, 2005)
  • K023704 — KSEA SCB ACC CONTROL (January 30, 2003)
  • K020640 — KSEA SCB MEDIA CONTROL (May 28, 2002)

FDA data resources