Radiance

16 catalogue numbers from HP 600-800 GY9.5, listed by Blv Licht-Und Vakuumtechnik GmbH, Germany, under Booth, Sun Tan. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
16catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LEJ
Manufacturer City Province Registered as Device types
Global Fabtech Wheel Chair (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 15

Record

Regulatory record for Radiance
Listed by Blv Licht-Und Vakuumtechnik GmbH, Germany
FDA product code LEJ
Device type Booth, Sun Tan
Device class Class 2
Regulation 21 CFR 878.4635
Record published 2020-12-07
Record revised 2023-08-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Packaging Carton box of 25
Distribution end date 2024-06-21

Catalogue Numbers

Catalogue numbers for Radiance
Catalogue number Size Status
HP 600-800 GY9.5 In distribution
HP 300-520W GY9.5 In distribution
HP 400-500W R7s In distribution
HP 600-650W GY9.5 Withdrawn
HP 1000-1400W L Withdrawn
HP 630W P Withdrawn
HP 1000-1400W L Withdrawn
HP 600-650W GY9.5 Withdrawn
HP 620W L Withdrawn
HP 620W L Withdrawn
HP 800-1000W GY9.5c Withdrawn
HP 630W P Withdrawn
HP 300-520W GY9.5 Withdrawn
HP 400-500W R7s Withdrawn
HP 600-800 GY9.5 Withdrawn
HP 800-1000W GY9.5c Withdrawn

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K152141 2016-02-25

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer