510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K861989Substantially Equivalent

Modification of Suntana Sun System Bed

Hawaiian Tan SpA, Huntsville AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861989 is the FDA 510(k) clearance record for MODIFICATION OF SUNTANA SUN SYSTEM BED, a class II device, cleared for Hawaiian Tan Spa on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list one 510(k) clearance for Hawaiian Tan Spa. As of , FDA records show no recalls naming K861989.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Hawaiian Tan Spa 1219 Jordan Ln., Huntsville AL
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