510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K940753Substantially Equivalent

Tan America Sun Up

Tan America, Rancho Cordova CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940753 is the FDA 510(k) clearance record for TAN AMERICA SUN UP, a class II device, cleared for Tan America on under FDA product code LEJ (Booth, Sun Tan). FDA records list one 510(k) clearance for Tan America. As of , FDA records show no recalls naming K940753.

Clearance record

Decision date
Received
(46 days to decision)
Product code
LEJ Booth, Sun Tan
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tan America 2668 Mercantile Dr., Rancho Cordova CA
510(k) summary
Statement
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