510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914759Substantially Equivalent

Bloom Transparent Stencil

Freckles Publications, Inc., Lubbock TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914759 is the FDA 510(k) clearance record for BLOOM TRANSPARENT STENCIL, a class I device, cleared for Freckles Publications, Inc. on under FDA product code FZZ (Marker, Skin). FDA records list one 510(k) clearance for Freckles Publications, Inc. As of , FDA records show no recalls naming K914759.

Clearance record

Decision date
Received
(182 days to decision)
Product code
FZZ Marker, Skin
Regulation
21 CFR 878.4660
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Freckles Publications, Inc. C/O Coffee - Novak, Attorneys, Lubbock TX
510(k) summary
Statement
Third party review
No

Clearances, product code FZZ

Trailing 12 months

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

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