510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180555Substantially Equivalent

Ergoline Prestige 1600 Hybrid Performance

Jk-Holding GmbH, Windhagen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180555 is the FDA 510(k) clearance record for Ergoline Prestige 1600 Hybrid Performance, a class II device, cleared for Jk Holding GmbH on under FDA product code LEJ (Booth, Sun Tan). FDA records list 6 510(k) clearances for Jk Holding GmbH, from to . As of , FDA records show no recalls naming K180555.

Clearance record

Decision date
Received
(224 days to decision)
Product code
LEJ Booth, Sun Tan
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Jk Holding GmbH Koehlershohner Strasse 60, Windhagen, DE
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