LEJ — Booth, Sun Tan Class II

FDA Device Classification

Classification Details

Product Code
LEJ
Device Class
Class II
Regulation Number
878.4635
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221523unilam coTanning LampFebruary 15, 2023
K220500jk-holdingErgoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet FitJuly 1, 2022
K191881kblKBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunOctober 28, 2019
K190173jk-holdingErgoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 HybMay 10, 2019
K183539jk-holdingErgoline Sunrise 7200 Hybrid TechnologyApril 8, 2019
K180555jk holdingErgoline Prestige 1600 Hybrid PerformanceOctober 11, 2018
K181455prosun internationalProSun sunlamp products, Luxura sunlamp productsSeptember 10, 2018
K151721kdb inc. (dba) sperti sunlampFIJI SUN FLUORESCENT TANNING UNITJune 22, 2018
K180581feilo sylvania germanyUV Lamps for Sunlamp ProductsJune 22, 2018
K180576lpiSolar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite anApril 19, 2018
K173565jk-holdingSunrise 6200, Sunrise 7200February 14, 2018
K161394sportarredo group s.cHPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxJuly 6, 2017
K151962kblKBL Sunlamp Products (= Device Bundling name)September 15, 2016
K152405ibl acquisitionsIBL 5000 Tanning BoothSeptember 1, 2016
K152423sunfire industriesSunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; SunfiMay 20, 2016
K152452medtek lighting corp d/b/a peacock tanningPeacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200May 19, 2016
K152336j and b products ltd dba hex tanningHEX tanning boothMay 2, 2016
K152412tanses technologiesT-32;T-40;T-44;T-52;T-72;TT-50April 29, 2016
K152364pc marketinguwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUSApril 14, 2016
K152238sun capsuleSun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, SuMarch 4, 2016