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510(k) K922279

ILLUMINATOR IV MINOR SURGERY LIGHT by Medical Illumination, Inc. — Product Code FSW

K922279 is an FDA 510(k) premarket notification submitted by Medical Illumination, Inc. for the device "ILLUMINATOR IV MINOR SURGERY LIGHT". The FDA issued a decision of Substantially Equivalent on September 2, 1992. The device falls under product code FSW (Light, Surgical, Endoscopic), 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
September 2, 1992
Date Received
May 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Endoscopic
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)
  • K930897 — MI-15 EXAM SURGICAL LIGHT (June 25, 1993)
  • K925710 — M.E.D. LIGHT (June 4, 1993)
  • K922282 — ILLUMINATOR VIII ULTRA/SPOT (March 4, 1993)
  • K922278 — ILLUMINATOR III (March 4, 1993)
  • K922280 — ILLUMINATOR VII MINI/LUM LIGHT (February 5, 1993)
  • K922277 — ILLUMINATOR II (February 5, 1993)
  • K922281 — ILLUMINATOR VII MINI/SPOT LIGHT (February 5, 1993)

Other clearances for product code FSW

  • K022989 — RADLITE TISSUE RETRACTOR SYSTEM (November 25, 2002)
  • K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (February 1, 2002)
  • K943342 — MEDICAM XENON LIGHT SOURCE (October 17, 1994)
  • K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE (November 18, 1993)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K894319 — MEDICAL DYNAMICS LIGHT SOURCE (October 3, 1989)
  • K870898 — ULTRA-LUX LIGHT SOURCE (March 18, 1987)

FDA data resources