Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LEJ — Predicate Candidate Screening
81 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
265 days90th percentile
81clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221523 | Tanning Lamp | Unilam Co., Ltd. | 2023-02-15 | 265 | 0 |
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by | Jk-Holding GmbH | 2022-07-01 | 129 | 0 |
| K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 | Kbl GmbH | 2019-10-28 | 105 | 0 |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline | Jk-Holding GmbH | 2019-05-10 | 98 | 0 |
| K183539 | Ergoline Sunrise 7200 Hybrid Technology | Jk-Holding GmbH | 2019-04-08 | 109 | 0 |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | Jk Holding GmbH | 2018-10-11 | 224 | 0 |
| K181455 | ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC | 2018-09-10 | 98 | 0 |
| K151721 | FIJI SUN FLUORESCENT TANNING UNIT | Kdb Inc. (Dba) Sperti Sunlamp | 2018-06-22 | 1093 | 0 |
| K180581 | UV Lamps for Sunlamp Products | Feilo Sylvania Germany GmbH | 2018-06-22 | 113 | 0 |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Gra | Lpi, Inc. | 2018-04-19 | 45 | 0 |
| K173565 | Sunrise 6200, Sunrise 7200 | Jk-Holding GmbH | 2018-02-14 | 89 | 0 |
| K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New | Sportarredo Group S.C. | 2017-07-06 | 413 | 0 |
| K151962 | KBL Sunlamp Products (= Device Bundling name) | Kbl AG | 2016-09-15 | 427 | 0 |
| K152405 | IBL 5000 Tanning Booth | Ibl Acquisitions, LLC | 2016-09-01 | 373 | 0 |
| K152423 | Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 T | Sunfire Industries, Inc. | 2016-05-20 | 268 | 0 |
| K152452 | Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/200 | Medtek Lighting Corp D/B/A Peacock Tanning | 2016-05-19 | 265 | 0 |
| K152336 | HEX tanning booth | J & B Products Ltd Dba Hex Tanning | 2016-05-02 | 257 | 0 |
| K152412 | T-32;T-40;T-44;T-52;T-72;TT-50 | Tanses Technologies, Inc. | 2016-04-29 | 247 | 0 |
| K152364 | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBU | Pc Marketing, Inc. | 2016-04-14 | 237 | 0 |
| K152238 | Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Caps | Sun Capsule, Inc. | 2016-03-04 | 207 | 0 |
| K151905 | 3400E series; E5400 series; E6400 series; Sundazzler series | Heartland Tanning, Inc. | 2016-03-01 | 232 | 0 |
| K152141 | High Pressure Tanning Lamps | Blv Licht-Und Vakuumtechnik GmbH | 2016-02-25 | 206 | 0 |
| K152233 | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun | Sportarredo Group S.C. | 2016-01-27 | 173 | 0 |
| K151370 | UV Lamps for Indoor Tanning Devices | Light Sources, Inc. | 2015-12-17 | 210 | 0 |
| K152436 | Suntanning Lamps | Interlectric Corporation | 2015-12-07 | 102 | 0 |
| K152273 | Cosmedico Ultraviolet Lamps of Various Models | Cosmedico Light, Inc. | 2015-10-30 | 79 | 0 |
| K152095 | Ultraviolet Lamps Intended for Use in Sunlamp Products (comm | Cosmedico Light, Inc. | 2015-10-28 | 92 | 0 |
| K151674 | Ultraviolet Sun Tanning Lamp | G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh | 2015-10-20 | 120 | 0 |
| K151841 | Ultraviolet Sunlamps | Wolff System Technology Corp. | 2015-10-05 | 91 | 0 |
| K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sun | Jk Holding GmbH | 2015-09-16 | 113 | 0 |
| K150778 | Various Brands of Ultraviolet Lamps | Cosmedico Light, Inc. | 2015-05-29 | 65 | 0 |
| K143043 | Tanning Lamp | Unilam Co., Ltd. | 2015-04-02 | 162 | 0 |
| K090831 | TANTHERA-T35 | Tanthera, Inc. | 2009-05-29 | 64 | 0 |
| K944015 | HARPO SUNBED, SUN TANNING MACHINE | Harpo Industries | 1994-09-06 | 25 | 0 |
| K943656 | ALPHA SOLAR SYSTEM TANNING BED | Heartland Tan Systems | 1994-08-15 | 18 | 0 |
| K936314 | ODYSSEY TAN 2000 | Fitness TO Go, Inc. | 1994-07-22 | 214 | 0 |
| K940753 | TAN AMERICA SUN UP | Tan America | 1994-04-05 | 46 | 0 |
| K940672 | CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL10 | Philips Lighting Co. | 1994-03-18 | 30 | 0 |
| K932483 | SUNDASH | Sun Ind., Inc. | 1994-02-22 | 274 | 1 |
| K935854 | ULTRAVIOLET LAMPS FOR TANNING | Cosmedico Light, Inc. | 1994-01-24 | 47 | 0 |
| K931661 | ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED | Eurocut, Ltd. | 1993-12-17 | 256 | 0 |
| K931660 | ULTRABRONZ SERIES 400 TANNING BED | Eurocut, Ltd. | 1993-12-17 | 256 | 0 |
| K932418 | SUNBRONZE TANNING LAMPS | Ess Lighting | 1993-12-09 | 205 | 0 |
| K923759 | FLUORESCENT T12 UVA TANNING LAMP | Quality Lamp, Inc. | 1993-12-09 | 499 | 0 |
| K904644 | EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 | Eurosun, Inc. | 1990-12-28 | 78 | 0 |
| K901714 | LIFESTYLE HOME TANNING UNITS | Life Products, Inc. | 1990-06-27 | 75 | 0 |
| K896983 | SUNBRONZE SB24C/65 ULTRA | Sunbronze | 1990-01-03 | 20 | 0 |
| K895409 | REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER | Remington Products Company, LLC | 1989-10-20 | 44 | 0 |
| K895325 | SUNTANNING BED | Sunbronze | 1989-09-15 | 17 | 0 |
| K882331 | SHAW SUN SYSTEMS MODEL 1600 | Shaw Sun Systems | 1988-06-22 | 16 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda