510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993300Substantially Equivalent

Coldlightsource Pl3000

Fiber Imaging Technologies, Inc., Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993300 is the FDA 510(k) clearance record for COLDLIGHTSOURCE PL3000, a class II device, cleared for Fiber Imaging Technologies, Inc. on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list 5 510(k) clearances for Fiber Imaging Technologies, Inc., from to . As of , FDA records show no recalls naming K993300.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fiber Imaging Technologies, Inc. 45 Pontiac Rd., Newton MA
510(k) summary
Summary
Third party review
No

Clearances, product code FCW

Trailing 12 months

FDA records hold no clearances under product code FCW in the trailing twelve months.

FDA records show no clearances under product code FCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260