FDA product code LEJ: Booth, Sun Tan
LEJ is the FDA product code for booth, sun tan. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel. FDA has cleared 81 510(k) submissions under LEJ, 2 in the last five years, from 64 different applicants. The average 510(k) review took 128 days (median 73). FDA has posted 6 recalls for LEJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Booth, Sun Tan |
| Device class | Class II |
| Regulation | 21 CFR 878.4635 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LEJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 413 |
| 2018 | 6 | 277 |
| 2019 | 3 | 104 |
| 2022 | 1 | 129 |
| 2023 | 1 | 265 |
Compare with all 510(k) review times · Search every LEJ clearance
Top LEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jk-Holding GmbH | 4 | 2022-07-01 |
| Cosmedico Light, Inc. | 4 | 2015-10-30 |
| Unilam Co., Ltd. | 2 | 2023-02-15 |
| Jk Holding GmbH | 2 | 2018-10-11 |
| Sportarredo Group S.C. | 2 | 2017-07-06 |
59 more applicants have LEJ clearances. See the full list in Caduvo.
Most recent LEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221523 | Unilam Co., Ltd. | Tanning Lamp | 2023-02-15 | 265 |
| K220500 | Jk-Holding GmbH | 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 | 2022-07-01 | 129 |
| K191881 | Kbl GmbH | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | 2019-10-28 | 105 |
| K190173 | Jk-Holding GmbH | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | 2019-05-10 | 98 |
| K183539 | Jk-Holding GmbH | Ergoline Sunrise 7200 Hybrid Technology | 2019-04-08 | 109 |
Recalls for LEJ devices
6 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-31.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code LEJ?
LEJ is the FDA product code for booth, sun tan. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel.
What device class is LEJ?
Class II, regulation 21 CFR 878.4635. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEJ?
Across 81 cleared submissions the average was 128 days from receipt to decision (median 73).
Which companies have the most LEJ clearances?
Jk-Holding GmbH (4); Cosmedico Light, Inc. (4); Unilam Co., Ltd. (2); Jk Holding GmbH (2); Sportarredo Group S.C. (2).
Have LEJ devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2023-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code LEJ
- Run a recall and safety report across every LEJ manufacturer
- Watch product code LEJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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