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510(k) K964586

PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 by Iba/Griffith — Product Code FCW

K964586 is an FDA 510(k) premarket notification submitted by Iba/Griffith for the device "PRESCOTT'S LIGHT SOURCE MODEL NO. II-150". The FDA issued a decision of Substantially Equivalent on January 17, 1997. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
November 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K082813 — STRYKER LED LIGHTSOURCE (December 19, 2008)
  • K081477 — LUXTEC MLX LIGHT SOURCE (June 18, 2008)
  • K032430 — ACUEITY MEDICAL LIGHT SOURCE (September 5, 2003)
  • K012265 — METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (October 17, 2001)

FDA data resources