uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
FDA 510(k) K152364 · Pc Marketing, Inc.
510(k) numberK152364
Submission
- Device name
- uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
- Applicant
- Pc Marketing, Inc.
Ridgefield, NJ, US - Received
- August 21, 2015
- Decision date
- April 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEJ – Booth, Sun Tan
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4635
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LEJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221523 | Tanning LampLEJ · Traditional | Unilam Co., Ltd. | 02/15/2023SE |
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness…LEJ · Traditional | Jk-Holding GmbH | 07/01/2022SE |
| K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunLEJ · Special | Kbl GmbH | 10/28/2019SE |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid…LEJ · Traditional | Jk-Holding GmbH | 05/10/2019SE |
| K183539 | Ergoline Sunrise 7200 Hybrid TechnologyLEJ · Traditional | Jk-Holding GmbH | 04/08/2019SE |
| K180555 | Ergoline Prestige 1600 Hybrid PerformanceLEJ · Traditional | Jk Holding GmbH | 10/11/2018SE |
| K181455 | ProSun sunlamp products, Luxura sunlamp productsLEJ · Traditional | Prosun International, LLC | 09/10/2018SE |
| K180581 | UV Lamps for Sunlamp ProductsLEJ · Traditional | Feilo Sylvania Germany GmbH | 06/22/2018SE |
| K151721 | Fiji Sun Fluorescent Tanning UnitLEJ · Abbreviated | Kdb Inc. (Dba) Sperti Sunlamp | 06/22/2018SE |
| K180576 | Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and…LEJ · Traditional | Lpi, Inc. | 04/19/2018SE |
Questions and answers
When was uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS cleared by the FDA?
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS (K152364) received a 510(k) decision of Substantially Equivalent on April 14, 2016, 237 days after the submission was received.
What is the product code of K152364?
The FDA product code is LEJ – Booth, Sun Tan, a Class II (moderate risk) device regulated under 21 CFR 878.4635.