Coldlightsource PL3000

FDA 510(k) K993300 · Fiber Imaging Technologies, Inc.

Substantially Equivalent

510(k) numberK993300

Submission

Device name
Coldlightsource PL3000
Applicant
Fiber Imaging Technologies, Inc.
Newton, MA, US
Received
October 1, 1999
Decision date
November 5, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FCW – Light Source, Fiberoptic, Routine
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

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Questions and answers

When was Coldlightsource PL3000 cleared by the FDA?

Coldlightsource PL3000 (K993300) received a 510(k) decision of Substantially Equivalent on November 5, 1999, 35 days after the submission was received.

What is the product code of K993300?

The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.