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510(k) K151905

Device
3400E Series; E5400 Series; E6400 Series; Sundazzler Series
Applicant
HEARTLAND TANNING, INC.
510(k) number
K151905
Product code
LEJ  
Decision
Substantially Equivalent (SESE)
Decision date
2016-03-01
Date received
2015-07-13
Regulation
878.4635
Classification name
Booth, Sun Tan
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Jon Marcum
Address
4251 NE Port Dr. Lees Summit MO US 64064 64064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LEJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221523Tanning LampUnilam Co., Ltd.2023-02-15
K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbH2022-07-01
K191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbH2019-10-28
K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbH2019-05-10
K183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbH2019-04-08
K180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH2018-10-11
K181455ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC2018-09-10
K151721FIJI SUN FLUORESCENT TANNING UNITKdb Inc. (Dba) Sperti Sunlamp2018-06-22
K180581UV Lamps for Sunlamp ProductsFeilo Sylvania Germany GmbH2018-06-22
K180576Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)Lpi, Inc.2018-04-19
K173565Sunrise 6200, Sunrise 7200Jk-Holding GmbH2018-02-14
K161394HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C.2017-07-06
K151962KBL Sunlamp Products (= Device Bundling name)Kbl AG2016-09-15
K152405IBL 5000 Tanning BoothIbl Acquisitions, LLC2016-09-01
K152423Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning CanopySunfire Industries, Inc.2016-05-20

Legacy Summary#

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FDA Review#

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