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Heraeus Noblelight America LLC

G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH · Model Strahler MAT 1000 AF · UDI-DI 04054657500563

LEJ
10
510(k) clearances
134
Adverse events (2 deaths)
6
Recalls
20
Facilities

Description

UV - Tanning lamp, Accession # 1620 384-000 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com

Recalls

DateFirmReason
2023-03-31J&T Health and Wellness LLCIn some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
2018-12-10ProSun International, LLCProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
2018-12-10ProSun International, LLCProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
2017-12-02ProSun International, LLCThe 30 minute maximum tanning time has been reduced to 20 minutes.
2014-07-25JK Products & Services, IncThe integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
2005-07-08JK Products & Services, IncThe firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outsi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.