510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860859Substantially Equivalent

Uva Sun Systems

Bremi, Holland, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860859 is the FDA 510(k) clearance record for UVA SUN SYSTEMS, a class II device, cleared for Bremi on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list one 510(k) clearance for Bremi. As of , FDA records show no recalls naming K860859.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bremi Postbus 47, Holland, NL
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