KBL K7 Puresun
3 catalogue numbers from K7-p-46-4Hp-0 UP ep 05, listed by KBL GmbH, Germany, under Booth, Sun Tan. 1 manufacturer in China is registered for this product code.
1manufacturer
3catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
Record
| Listed by | KBL GmbH, Germany |
|---|---|
| FDA product code | LEJ |
| Device type | Booth, Sun Tan |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4635 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K151962 |
| Record published | 2022-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K7-p-46-4Hp-0 UP ep 05 | In distribution | |
| K7-p-46-4Hp-2s UP ep 05 | In distribution | |
| K7-p-46-4Hp-2s UP cpi 05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Genesis | Light Sources, Inc. | 65 |
| Booth, Sun Tan | Unilam Co., Ltd. | 64 |
| Renuvatan | Light Sources, Inc. | 60 |
| Original Hanau | G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH | 43 |
| Rave | Light Sources, Inc. | 41 |
| Brilliance | Light Sources, Inc. | 32 |
| Supra | Blv Licht-Und Vakuumtechnik GmbH | 30 |
| pureSunlight | Narva Lichtquellen GmbH + Co. KG | 22 |
| Signature Series | Light Sources, Inc. | 21 |
| Tanses T-32 Series | Tanses Technologies, Inc. | 20 |
| Perfect Bronze | Narva Lichtquellen GmbH + Co. KG | 20 |
| ProSun | Prosun International, LLC | 19 |
Showing 12 of 659. All products under Booth, Sun Tan
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191881 | 2019-10-28 |
| K151962 | 2016-09-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.