Panels › General, Plastic Surgery › Product code LEJ · Class 2
Booth, Sun Tan
Regulation 878.4635
0510(k)s in 12 months (81 all time)
0recalls in 12 months (6 all time)
3recalls that name a 510(k)
Top companies in LEJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Jk Holding GmbH | 6 | 0 |
| Cosmedico Light, Inc. | 4 | 0 |
| Prosun International, LLC | 1 | 3 |
| Eurocut, Ltd. | 2 | 0 |
| Health Systems Intl., Inc. | 2 | 0 |
| JK Products & Services, Inc | 0 | 2 |
| Kbl AG | 2 | 0 |
| Kohler | 2 | 0 |
| Rami-Tan | 2 | 0 |
| Sportarredo Group S.C. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 2023 | K221523 | Tanning Lamp Unilam Co., Ltd., KR | LEJ |
| Jul 1, 2022 | K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vita Jk-Holding GmbH, DE | LEJ |
| Oct 28, 2019 | K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun Kbl GmbH, DE | LEJ |
| May 10, 2019 | K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Pl Jk-Holding GmbH, DE | LEJ |
| Apr 8, 2019 | K183539 | Ergoline Sunrise 7200 Hybrid Technology Jk-Holding GmbH, DE | LEJ |
| Oct 11, 2018 | K180555 | Ergoline Prestige 1600 Hybrid Performance Jk Holding GmbH, DE | LEJ |
| Sep 10, 2018 | K181455 | ProSun sunlamp products, Luxura sunlamp products Prosun International, LLC | LEJ |
| Jun 22, 2018 | K180581 | UV Lamps for Sunlamp Products Feilo Sylvania Germany GmbH, DE | LEJ |
| Jun 22, 2018 | K151721 | FIJI SUN FLUORESCENT TANNING UNIT Kdb Inc. (Dba) Sperti Sunlamp | LEJ |
| Apr 19, 2018 | K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) Lpi, Inc. | LEJ |
| Feb 14, 2018 | K173565 | Sunrise 6200, Sunrise 7200 Jk-Holding GmbH, DE | LEJ |
| Jul 6, 2017 | K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux Sportarredo Group S.C., IT | LEJ |
| Sep 15, 2016 | K151962 | KBL Sunlamp Products (= Device Bundling name) Kbl AG, DE | LEJ |
| Sep 1, 2016 | K152405 | IBL 5000 Tanning Booth Ibl Acquisitions, LLC | LEJ |
| May 20, 2016 | K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy Sunfire Industries, Inc. | LEJ |
| May 19, 2016 | K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 Medtek Lighting Corp D/B/A Peacock Tanning | LEJ |
| May 2, 2016 | K152336 | HEX tanning booth J & B Products Ltd Dba Hex Tanning | LEJ |
| Apr 29, 2016 | K152412 | T-32;T-40;T-44;T-52;T-72;TT-50 Tanses Technologies, Inc., CA | LEJ |
| Apr 14, 2016 | K152364 | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS Pc Marketing, Inc. | LEJ |
| Mar 4, 2016 | K152238 | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54 Sun Capsule, Inc. | LEJ |
| Mar 1, 2016 | K151905 | 3400E series; E5400 series; E6400 series; Sundazzler series Heartland Tanning, Inc. | LEJ |
| Feb 25, 2016 | K152141 | High Pressure Tanning Lamps Blv Licht-Und Vakuumtechnik GmbH, DE | LEJ |
| Jan 27, 2016 | K152233 | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux Sportarredo Group S.C., IT | LEJ |
| Dec 17, 2015 | K151370 | UV Lamps for Indoor Tanning Devices Light Sources, Inc. | LEJ |
| Dec 7, 2015 | K152436 | Suntanning Lamps Interlectric Corporation | LEJ |
| Oct 30, 2015 | K152273 | Cosmedico Ultraviolet Lamps of Various Models Cosmedico Light, Inc. | LEJ |
| Oct 28, 2015 | K152095 | Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) Cosmedico Light, Inc. | LEJ |
| Oct 20, 2015 | K151674 | Ultraviolet Sun Tanning Lamp G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh, DE | LEJ |
| Oct 5, 2015 | K151841 | Ultraviolet Sunlamps Wolff System Technology Corp. | LEJ |
| Sep 16, 2015 | K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products Jk Holding GmbH, DE | LEJ |
| May 29, 2015 | K150778 | Various Brands of Ultraviolet Lamps Cosmedico Light, Inc. | LEJ |
| Apr 2, 2015 | K143043 | Tanning Lamp Unilam Co., Ltd., KR | LEJ |
| May 29, 2009 | K090831 | TANTHERA-T35 Tanthera, Inc. | LEJ |
| Sep 6, 1994 | K944015 | HARPO SUNBED, SUN TANNING MACHINE Harpo Industries, NL | LEJ |
| Aug 15, 1994 | K943656 | ALPHA SOLAR SYSTEM TANNING BED Heartland Tan Systems | LEJ |
| Jul 22, 1994 | K936314 | ODYSSEY TAN 2000 Fitness TO Go, Inc. | LEJ |
| Apr 5, 1994 | K940753 | TAN AMERICA SUN UP Tan America | LEJ |
| Mar 18, 1994 | K940672 | CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL Philips Lighting Co. | LEJ |
| Feb 22, 1994 | K932483 | SUNDASH Sun Ind., Inc. | LEJ |
| Jan 24, 1994 | K935854 | ULTRAVIOLET LAMPS FOR TANNING Cosmedico Light, Inc. | LEJ |
| Dec 17, 1993 | K931661 | ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED Eurocut, Ltd. | LEJ |
| Dec 17, 1993 | K931660 | ULTRABRONZ SERIES 400 TANNING BED Eurocut, Ltd. | LEJ |
| Dec 9, 1993 | K932418 | SUNBRONZE TANNING LAMPS Ess Lighting | LEJ |
| Dec 9, 1993 | K923759 | FLUORESCENT T12 UVA TANNING LAMP Quality Lamp, Inc. | LEJ |
| Dec 28, 1990 | K904644 | EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 Eurosun, Inc. | LEJ |
| Jun 27, 1990 | K901714 | LIFESTYLE HOME TANNING UNITS Life Products, Inc. | LEJ |
| Jan 3, 1990 | K896983 | SUNBRONZE SB24C/65 ULTRA Sunbronze | LEJ |
| Oct 20, 1989 | K895409 | REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER Remington Products Company, LLC | LEJ |
| Sep 15, 1989 | K895325 | SUNTANNING BED Sunbronze | LEJ |
| Jun 22, 1988 | K882331 | SHAW SUN SYSTEMS MODEL 1600 Shaw Sun Systems | LEJ |
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