FDA Product Code
FDA Product Code LEJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4635
510(k) Clearances — 81 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221523 | Tanning Lamp | Unilam Co., Ltd. | 2023-02-15 | Traditional | PDF ↗ |
| 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 | Jk-Holding GmbH | 2022-07-01 | Traditional | PDF ↗ |
| K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | Kbl GmbH | 2019-10-28 | Special | PDF ↗ |
| 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 GmbH | 2019-05-10 | Traditional | PDF ↗ |
| K183539 | Ergoline Sunrise 7200 Hybrid Technology | Jk-Holding GmbH | 2019-04-08 | Traditional | PDF ↗ |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | Jk Holding GmbH | 2018-10-11 | Traditional | PDF ↗ |
| K181455 | ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC | 2018-09-10 | Traditional | PDF ↗ |
| K180581 | UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH | 2018-06-22 | Traditional | PDF ↗ |
| K151721 | FIJI SUN FLUORESCENT TANNING UNIT | Kdb Inc. (Dba) Sperti Sunlamp | 2018-06-22 | Abbreviated | PDF ↗ |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) | Lpi, Inc. | 2018-04-19 | Traditional | PDF ↗ |
| K173565 | Sunrise 6200, Sunrise 7200 | Jk-Holding GmbH | 2018-02-14 | Traditional | PDF ↗ |
| K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | Sportarredo Group S.C. | 2017-07-06 | Traditional | PDF ↗ |
| K151962 | KBL Sunlamp Products (= Device Bundling name) | Kbl AG | 2016-09-15 | Traditional | PDF ↗ |
| K152405 | IBL 5000 Tanning Booth | Ibl Acquisitions, LLC | 2016-09-01 | Traditional | PDF ↗ |
| K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy | Sunfire Industries, Inc. | 2016-05-20 | Traditional | PDF ↗ |
| K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 | Medtek Lighting Corp D/B/A Peacock Tanning | 2016-05-19 | Traditional | PDF ↗ |
| K152336 | HEX tanning booth | J & B Products Ltd Dba Hex Tanning | 2016-05-02 | Traditional | PDF ↗ |
| K152412 | T-32;T-40;T-44;T-52;T-72;TT-50 | Tanses Technologies, Inc. | 2016-04-29 | Traditional | PDF ↗ |
| K152364 | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS | Pc Marketing, Inc. | 2016-04-14 | Traditional | PDF ↗ |
| 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 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5 | Sun Capsule, Inc. | 2016-03-04 | Traditional | PDF ↗ |
| K151905 | 3400E series; E5400 series; E6400 series; Sundazzler series | Heartland Tanning, Inc. | 2016-03-01 | Traditional | PDF ↗ |
| K152141 | High Pressure Tanning Lamps | Blv Licht-Und Vakuumtechnik GmbH | 2016-02-25 | Traditional | PDF ↗ |
| K152233 | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | Sportarredo Group S.C. | 2016-01-27 | Traditional | PDF ↗ |
| K151370 | UV Lamps for Indoor Tanning Devices | Light Sources, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K152436 | Suntanning Lamps | Interlectric Corporation | 2015-12-07 | Traditional | PDF ↗ |
| K152273 | Cosmedico Ultraviolet Lamps of Various Models | Cosmedico Light, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K152095 | Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) | Cosmedico Light, Inc. | 2015-10-28 | Traditional | PDF ↗ |
| K151674 | Ultraviolet Sun Tanning Lamp | G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh | 2015-10-20 | Traditional | PDF ↗ |
| K151841 | Ultraviolet Sunlamps | Wolff System Technology Corp. | 2015-10-05 | Traditional | PDF ↗ |
| K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products | Jk Holding GmbH | 2015-09-16 | Traditional | PDF ↗ |
| K150778 | Various Brands of Ultraviolet Lamps | Cosmedico Light, Inc. | 2015-05-29 | Traditional | PDF ↗ |
| K143043 | Tanning Lamp | Unilam Co., Ltd. | 2015-04-02 | Traditional | PDF ↗ |
| K090831 | TANTHERA-T35 | Tanthera, Inc. | 2009-05-29 | Traditional | PDF ↗ |
| K944015 | HARPO SUNBED, SUN TANNING MACHINE | Harpo Industries | 1994-09-06 | Traditional | PDF ↗ |
| K943656 | ALPHA SOLAR SYSTEM TANNING BED | Heartland Tan Systems | 1994-08-15 | Traditional | PDF ↗ |
| K936314 | ODYSSEY TAN 2000 | Fitness TO Go, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K940753 | TAN AMERICA SUN UP | Tan America | 1994-04-05 | Traditional | PDF ↗ |
| K940672 | CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL | Philips Lighting Co. | 1994-03-18 | Traditional | PDF ↗ |
| K932483 | SUNDASH | Sun Ind., Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K935854 | ULTRAVIOLET LAMPS FOR TANNING | Cosmedico Light, Inc. | 1994-01-24 | Traditional | PDF ↗ |
| K931661 | ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED | Eurocut, Ltd. | 1993-12-17 | Traditional | PDF ↗ |
| K931660 | ULTRABRONZ SERIES 400 TANNING BED | Eurocut, Ltd. | 1993-12-17 | Traditional | PDF ↗ |
| K923759 | FLUORESCENT T12 UVA TANNING LAMP | Quality Lamp, Inc. | 1993-12-09 | Traditional | PDF ↗ |
| K932418 | SUNBRONZE TANNING LAMPS | Ess Lighting | 1993-12-09 | Traditional | PDF ↗ |
| K904644 | EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 | Eurosun, Inc. | 1990-12-28 | Traditional | PDF ↗ |
| K901714 | LIFESTYLE HOME TANNING UNITS | Life Products, Inc. | 1990-06-27 | Traditional | PDF ↗ |
| K896983 | SUNBRONZE SB24C/65 ULTRA | Sunbronze | 1990-01-03 | Traditional | PDF ↗ |
| K895409 | REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER | Remington Products Company, LLC | 1989-10-20 | Traditional | PDF ↗ |
| K895325 | SUNTANNING BED | Sunbronze | 1989-09-15 | Traditional | PDF ↗ |
| K882331 | SHAW SUN SYSTEMS MODEL 1600 | Shaw Sun Systems | 1988-06-22 | Traditional | PDF ↗ |
| K881492 | MTI WOLFF SYSTEM, TANNING BED | Health Systems Intl., Inc. | 1988-04-19 | Traditional | PDF ↗ |
| K881409 | SUN SHELL (SUN TANNING BED) | Indoor Sun Systems, Inc. | 1988-04-19 | Traditional | PDF ↗ |
| K881353 | MTI WOLFF SYSTEM | Health Systems Intl., Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K875190 | ULTRA TAN PURPLE PRO | Ultra Tan Intl. AB | 1988-01-14 | Traditional | PDF ↗ |
| K875189 | ULTRA TAN PURPLE MINT | Ultra Tan Intl. AB | 1988-01-14 | Traditional | PDF ↗ |
| K873589 | PERFECT SUNTANNING BED | Wolff System Technology Corp. | 1987-10-29 | Traditional | PDF ↗ |
| K813207 | K51,K52 ENVIRONMENT ENCLOSURE | Kohler | 1981-12-31 | Traditional | PDF ↗ |
| K813208 | K60 HABITAT ENVIRONMENT ENCLOSURE | Kohler | 1981-12-31 | Traditional | PDF ↗ |
| K810366 | FANCY TAN SUNBED | Fancy Tan, Inc. | 1981-03-05 | Traditional | PDF ↗ |
| K803189 | SUNSCENE TANNING STUDIO | Sunscene Tanning Studio | 1981-01-28 | Traditional | PDF ↗ |
| K802756 | SEMI-OVAL MODULAR SUNTANNING BOOTH | Tannhut | 1981-01-22 | Traditional | PDF ↗ |
| K803090 | SUNMAKER (SUN TANNING BED) | Sunmaker, Inc. | 1981-01-22 | Traditional | PDF ↗ |
| K803061 | SUN TANNING DEVICES | Mutzhas Corp. | 1981-01-13 | Traditional | PDF ↗ |
| K802304 | SOLAR TONE | Bloomex International, Inc. | 1980-12-01 | Traditional | PDF ↗ |
| K802134 | JK INT'L, INC. SOLTRON UVA TANNING BED | Mottek Intl. Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K801675 | U.I. OCTOSON | Ausonics Pty , Ltd. | 1980-10-23 | Traditional | PDF ↗ |
| K801925 | CABANNA TAN SUNLAMP | The Marketing Exchange, Inc. | 1980-10-03 | Traditional | PDF ↗ |
| K801674 | SUN ROOM TANNING BOOTH | Sun Tan Enterprises, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801543 | SUN VALLEY TANS | Sun Valley Tans, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801752 | RAMI TAN ULTRAVIOLET B BOOTH | Rami-Tan | 1980-09-16 | Traditional | PDF ↗ |
| K801751 | RAMI ULTRAVIOLET A BOOTH | Rami-Tan | 1980-09-16 | Traditional | PDF ↗ |
| K801521 | CLASSIC TAN TANNING BOOTH | Classic Tan, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801542 | SUNBED/SUNROOF OR SUNCOUCH/SUNSKY | Sunfit, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801520 | SOLAR PACIFIC UVA SUNLAMP DEVICE | Solar Pacific | 1980-08-20 | Traditional | PDF ↗ |
| K801429 | SUNSATION | Fashion, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K801163 | SUNBURST, SUN SYSTEMS OR BC2 | Sun Ray Mfg., Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K801095 | THE SUN BOOTH | Sun Booths , Ltd. | 1980-07-21 | Traditional | PDF ↗ |
| K801341 | TAN YEAR ROUND SUN BED | Tan-Year Round, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K800744 | SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1 | Sun Ind., Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K800896 | WOLFF SYSTEM | Wolff System GmbH | 1980-05-30 | Traditional | PDF ↗ |
| K801029 | CLINICAL DATA SYSTEM (CAM) MODULE | Adac Laboratories | 1980-05-28 | Traditional | PDF ↗ |
Product code LEJ · Class II · General, Plastic Surgery. Data: openFDA.