Booth, Sun Tan
General, Plastic Surgery · 21 CFR 878.4635
Recent MDR events
134 adverse event reports on file
- SOLTRONDec 9, 2025MalfunctionJk Products Gmbh9615023-2025-00001
- EROGOLINE TANNING BEDOct 17, 2024InjuryJk Products & Services, Inc.MW5161215
- LUXURAFeb 22, 2024InjuryJ&t Health And Wellness Llc1000525872-2024-00401
- TANNING BED AT A SALONMay 17, 2023InjuryUnkMW5117576
- TANNING BED AT A SALONMay 17, 2023InjuryUnkMW5117577
- TANNING BEDSep 30, 2022MalfunctionUnkMW5112377
- TANNING BEDJul 28, 2022MalfunctionUnkMW5111182
- SPERTI SUNLAMPSApr 29, 2022InjuryKbd Inc1022129-2022-00001
- ASTRAL 150 - APAC1Mar 18, 2022MalfunctionResmed Ltd3007573469-2022-00179
- SPERTI SUNLAMPSJul 9, 2020InjuryKbd Inc.1022129-2020-00002
Event type breakdown
Recalls
6 recall events for this product code
- J&T Health and Wellness LLCOpen, ClassifiedSep 28, 2023
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
Z-2636-2023 · View FDA record ↗ - JK Products & Services, IncTerminatedSep 12, 2014
SUN DASH RADIUS 252 PN 8000809705.
The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
Z-2635-2014 · View FDA record ↗ - JK Products & Services, IncTerminatedSep 7, 2012
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation.
The 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 outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.
Z-2334-2012 · View FDA record ↗ - ProSun International, LLCTerminatedUnknown
Sundream 12 V tanning bed
The 30 minute maximum tanning time has been reduced to 20 minutes.
Z-0319-2018 · View FDA record ↗ - ProSun International, LLCTerminatedUnknown
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEA
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Z-1176-2019 · View FDA record ↗ - ProSun International, LLCTerminatedUnknown
ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Z-1177-2019 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Narva Lichtquellen Gmbh + Co. Kg
Brand-Erbisdorf Saxony, DE
Light Sources, Inc.
ORANGE, CT, US
Jk Products & Services, Inc.
JONESBORO, AR, US
Jw North America, Inc.
Cartersville, GA, US
Medtek Skin Care, Inc.
HUDSON FALLS, NY, US
Sportarredo Group S.c.
GRUARO Venezia, IT
Kbd, Inc.
North Las Vegas, NV, US
Jw North America, Inc.
Rockland, MA, US
Kbl Gmbh
Dernbach Rhineland-Palatinate, DE
Ultrasun
HENGELO Overijssel, NL
Lighttech Ltd.
DUNAKESZI Pest, HU
Tanses Technologies, Inc.
FABREVILLE Quebec, CA
Jk Products Gmbh
BAD HONNEF North Rhine-Westphalia, DE
Sunshine Usa, Llc
JC, TN, US
Ibl Acquisitions Llc
Indianapolis, IN, US
Ushio Germany Gmbh
Steinhoering Bavaria, DE
510(k) clearances
81 clearances for this product code
- Unilam Co., Ltd.Feb 15, 2023
K221523 · Tanning Lamp
- Jk-Holding GmbHJul 1, 2022
K220500 · Ergoline 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 Ergoline
- Kbl GmbHOct 28, 2019
K191881 · KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
- Jk-Holding GmbHMay 10, 2019
K190173 · Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
- Jk-Holding GmbHApr 8, 2019
K183539 · Ergoline Sunrise 7200 Hybrid Technology
- Jk Holding GmbHOct 11, 2018
K180555 · Ergoline Prestige 1600 Hybrid Performance
- Prosun International, LLCSep 10, 2018
K181455 · ProSun sunlamp products, Luxura sunlamp products
- Kdb Inc. (Dba) Sperti SunlampJun 22, 2018
K151721 · FIJI SUN FLUORESCENT TANNING UNIT