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510(k) K180576

Device
Solar Storm, Solar Wave, Sunco, And ESB (Avalon, Galaxy, Grande, Oasis, Elite And Leisure Select)
Applicant
LPI, Inc.
510(k) number
K180576
Product code
LEJ  
Decision
Substantially Equivalent (SESE)
Decision date
2018-04-19
Date received
2018-03-05
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christopher Steadman
Address
506 Twin Oaks Dr. Johnson City TN US 37601 37601

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K152452Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200Medtek Lighting Corp D/B/A Peacock Tanning2016-05-19

Legacy Summary#

summary

FDA Review#

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