Home / 510(k) Clearances / K930897

510(k) K930897

MI-15 EXAM SURGICAL LIGHT by Medical Illumination, Inc. — Product Code FTD

K930897 is an FDA 510(k) premarket notification submitted by Medical Illumination, Inc. for the device "MI-15 EXAM SURGICAL LIGHT". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code FTD (Lamp, Surgical), a Class II device regulated under 21 CFR 878.4580. Medical Illumination, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1993
Date Received
February 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Medical Illumination, Inc.

  • K931026 — MI-5 DIAGNOSTIC LIGHT (August 19, 1993)
  • K931646 — MI-4 VARIABLE SPOT LIGHT (August 19, 1993)
  • K925710 — M.E.D. LIGHT (June 4, 1993)
  • K922278 — ILLUMINATOR III (March 4, 1993)
  • K922282 — ILLUMINATOR VIII ULTRA/SPOT (March 4, 1993)
  • K922281 — ILLUMINATOR VII MINI/SPOT LIGHT (February 5, 1993)
  • K922277 — ILLUMINATOR II (February 5, 1993)
  • K922280 — ILLUMINATOR VII MINI/LUM LIGHT (February 5, 1993)
  • K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT (September 2, 1992)

Other clearances for product code FTD

  • K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL (December 5, 2013)
  • K130513 — VOLISTA 400; VOLISTA 600 (May 8, 2013)
  • K123776 — POLARIS 100/200 (March 8, 2013)
  • K111020 — ATRICURE DISSECTOR (June 9, 2011)
  • K100234 — HM-LAMP II (July 8, 2010)
  • K100884 — STRYKER KNIFELIGHT (June 25, 2010)
  • K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (June 20, 2007)
  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)
  • K041681 — ATRICURE DISSECTOR (July 1, 2004)
  • K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (December 13, 2001)

FDA data resources