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510(k) K921866

LUMINOUS 250 FIBEROPTIC ILLUMINATOR by Progressive Dynamics, Inc. — Product Code HBI

K921866 is an FDA 510(k) premarket notification submitted by Progressive Dynamics, Inc. for the device "LUMINOUS 250 FIBEROPTIC ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on July 8, 1992. The device falls under product code HBI (Illuminator, Fiberoptic, Surgical Field), a Class II device regulated under 21 CFR 878.4580. Progressive Dynamics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1992
Date Received
April 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Progressive Dynamics, Inc.

  • K952329 — LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM (January 17, 1996)
  • K944688 — LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR (November 1, 1994)
  • K933764 — LIFE-AIR 1000 PATIENT WARMING COVER (November 9, 1993)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K914382 — LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM (April 21, 1992)
  • K914383 — LIFE-AIR 1000 PATIENT WARMING COVERS (March 30, 1992)

Other clearances for product code HBI

  • K223183 — Light-Guide Cables (January 13, 2023)
  • K163185 — OptiLux LED Illuminator (November 21, 2016)
  • K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES (April 9, 2015)
  • K111342 — LIGHT GUIDE CABLE (November 25, 2011)
  • K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (October 31, 2005)
  • K021931 — ENDOSCOPIC FIBEROPTIC CABLE (September 6, 2002)
  • K991208 — ENDOSCOPIC FIBEROPTIC CABLE (June 23, 1999)
  • K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (December 16, 1998)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)

FDA data resources