LEJClass II

Booth, Sun Tan

21 CFR 878.4635 / General, Plastic Surgery

LEJ is the FDA product code for Booth, Sun Tan, a class II device type, regulated under 21 CFR 878.4635. As of 2026-09-10, FDA records hold 81 510(k) clearances under this code, the most recent dated 2023-02-15, and 6 recalls.

Classification record

Product code: LEJ
Device name: Booth, Sun Tan
Regulation: 21 CFR 878.4635
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 81
Ingested recalls: 6

Clearances, product code LEJ

By decision year

81 clearances under product code LEJ with a decision year between 1980 and 2023, 1980 the highest year at 18.

Show the numbers

510(k) clearances under FDA product code LEJ by decision year
Year	Clearances
1980	18
1981	7
1987	1
1988	6
1989	2
1990	3
1993	4
1994	7
2009	1
2015	9
2016	11
2017	1
2018	6
2019	3
2022	1
2023	1

Applicants with the most clearances

Product code LEJ

Applicants holding the most 510(k) clearances under product code LEJ
Applicant	Clearances
Jk-Holding GmbH	6
Cosmedico Light, Inc.	4
Eurocut, Ltd.	2
Health Systems Intl., Inc.	2
Kbl AG	2
Kohler	2
Rami-Tan	2
Sportarredo Group S.C.	2
Sun Ind., Inc.	2
Sunbronze	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order