510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860370Substantially Equivalent

Safe Sun 700 Home Tanning Unit

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

K860370 is the FDA 510(k) clearance record for SAFE SUN 700 HOME TANNING UNIT, a class II device, cleared for Safe Sun Corporation of America, Inc. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list one 510(k) clearance for Safe Sun Corporation of America, Inc. As of , FDA records show no recalls naming K860370.

Clearance record

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

Clearances, product code FTC

Trailing 12 months
3 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 20261