510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K875190Substantially Equivalent

Ultra Tan Purple Pro

Ultra Tan Intl. AB, Sweden, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875190 is the FDA 510(k) clearance record for ULTRA TAN PURPLE PRO, a class II device, cleared for Ultra Tan Intl. AB on under FDA product code LEJ (Booth, Sun Tan). FDA records list 2 510(k) clearances for Ultra Tan Intl. AB. As of , FDA records show no recalls naming K875190.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LEJ Booth, Sun Tan
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ultra Tan Intl. AB Box 80, Sweden, SE
Third party review
No

Clearances, product code LEJ

Trailing 12 months

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

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