Skip to the page
Get started – free

Data / Medical devices / Booth, Sun Tan

Booth, Sun Tan (LEJ): 18 FDA-registered makers in 9 countries

18 establishments in 9 countries are registered with the FDA to make Booth, Sun Tan (product code LEJ, Class 2, 21 CFR 878.4635). 14 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 81 510(k) clearances under this code, the latest on February 15, 2023, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LEJ
Device class
2
Regulation
878.4635
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States7
Germany4
Italy1
Hungary1
Canada1
Netherlands1
South Korea1
China1
Poland1

Makers of Booth, Sun Tan

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
JK Products GMBHBAD HONNEF North Rhine-Westphalia, GermanyManufacturer6July 1, 2022000api.fda.gov
JW North America, Inc.Rockland, MA, United StatesSpecification developer4October 30, 2015000api.fda.gov
Ibl Acquisitions LLCIndianapolis, IN, United StatesComplaint file establishment, Manufacturer, Specification developer3July 6, 2017000api.fda.gov
Sportarredo Group S.C.GRUARO Venezia, ItalyExporter to the US, Manufacturer3July 6, 2017000api.fda.gov
KBL GmbHDernbach Rhineland-Palatinate, GermanyComplaint file establishment, Manufacturer2October 28, 2019000api.fda.gov
Sunshine USA, LLCJc, TN, United StatesManufacturer2April 19, 2018000api.fda.gov
J&T Health and Wellness LLCSaint Petersburg, FL, United StatesComplaint file establishment, Manufacturer1September 10, 2018030api.fda.gov
KBD, Inc.North Las Vegas, NV, United StatesSpecification developer1June 22, 2018000api.fda.gov
Light Sources, Inc.Orange, CT, United StatesRepackager or relabeler, Specification developer1December 17, 2015000api.fda.gov
Lighttech Ltd.DUNAKESZI Pest, HungaryManufacturer1December 17, 2015000api.fda.gov
Medtek Skin Care, Inc.Hudson Falls, NY, United StatesManufacturer1May 19, 2016000api.fda.gov
Tanses Technologies, Inc.FABREVILLE Quebec, CanadaManufacturer1April 29, 2016000api.fda.gov
UltrasunHENGELO Overijssel, NetherlandsManufacturer1December 17, 2015000api.fda.gov
Unilam Co., Ltd.Ulju-Gun Ulsan, South KoreaManufacturer1February 15, 2023000api.fda.gov
Global Fabtech Wheel Chair (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
NARVA Lichtquellen GmbH + Co. KGBrand-Erbisdorf Saxony, GermanyContract manufacturer0000api.fda.gov
USHIO GERMANY GmbHSteinhoering Bavaria, GermanyContract manufacturer0000api.fda.gov
Ushio Poland SP. z o.oBlonie Mazowieckie, PolandContract manufacturer0000api.fda.gov

Updated February 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.