510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780125Substantially Equivalent

Fluoresoft

Holles Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780125 is the FDA 510(k) clearance record for FLUORESOFT, cleared for Holles Laboratories, Inc. on under FDA product code KYC. FDA records list one 510(k) clearance for Holles Laboratories, Inc. As of , FDA records show no recalls naming K780125.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KYC
Review panel
Unknown
Applicant
Holles Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KYC

Trailing 12 months

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

FDA records show no clearances under product code KYC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYC, 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