510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K152423Substantially Equivalent

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy

Sunfire Industries, Inc., New Bern NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152423 is the FDA 510(k) clearance record for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy, a class II device, cleared for Sunfire Industries, Inc. on under FDA product code LEJ (Booth, Sun Tan). FDA records list one 510(k) clearance for Sunfire Industries, Inc. As of , FDA records show no recalls naming K152423.

Clearance record

Decision date
Received
(268 days to decision)
Product code
LEJ Booth, Sun Tan
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sunfire Industries, Inc. 4905 Hwy. 70 E., New Bern NC
510(k) summary
Summary PDF
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