510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860566Substantially Equivalent

Nordic Sun 24 Lamp Tanning Bed

Nordic Sun Corporation of America, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860566 is the FDA 510(k) clearance record for NORDIC SUN 24 LAMP TANNING BED, a class II device, cleared for Nordic Sun Corporation of America on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 2 510(k) clearances for Nordic Sun Corporation of America. As of , FDA records show no recalls naming K860566.

Clearance record

Decision date
Received
(19 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nordic Sun Corporation of America 2770 Summer St., Stamford CT
Third party review
No

Clearances, product code FTC

Trailing 12 months
2 clearances under product code FTC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260