KBL K5 Hybridsun
Catalogue number K5-h-38-3Hp-0 UP ep 05, listed by KBL GmbH, Germany, under Booth, Sun Tan. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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) | K191881 |
| Record published | 2023-06-09 |
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 |
|---|---|---|
| K5-h-38-3Hp-0 UP ep 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.