510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854004Substantially Equivalent

Fluorescent T12 Uva Tanning Lamp

Light Sources, Inc., Ansonia CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854004 is the FDA 510(k) clearance record for FLUORESCENT T12 UVA TANNING LAMP, a class II device, cleared for Light Sources, Inc. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 9 510(k) clearances for Light Sources, Inc., from to . As of , FDA records show no recalls naming K854004.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Light Sources, Inc. P.O. Box 569, Ansonia 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