Genesis

FR71T12/BL/VHO/BP/3.5/230 160W

Registry build 21.09.26
1manufacturer
65catalogue 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 Genesis
Listed by Light Sources, Inc., United States
FDA product code LEJ
Device type Booth, Sun Tan
Device class Class 2
Regulation 21 CFR 878.4635
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2025-04-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Genesis
Catalogue number Size Status
3082 In distribution
3046 In distribution
2484 In distribution
1166 In distribution
1446 In distribution
3225 In distribution
2562 In distribution
3372 In distribution
1189 In distribution
3161 In distribution
2997 In distribution
2547 In distribution
3292 In distribution
3188 In distribution
3200 In distribution
1400 In distribution
2560 In distribution
3190 In distribution
2652 In distribution
3160 In distribution
3241 In distribution
3186 In distribution
3080 In distribution
3093 In distribution
1032 In distribution
1219 In distribution
3224 In distribution
3094 In distribution
2561 In distribution
1185 In distribution
2557 In distribution
3197 In distribution
3156 In distribution
3030 In distribution
3246 In distribution
1089 In distribution
3291 In distribution
2558 In distribution
2653 In distribution
3187 In distribution
2659 In distribution
2654 In distribution
3253 In distribution
2772 In distribution
3242 In distribution
2140 In distribution
3045 In distribution
2239 In distribution
3157 In distribution
3157 In distribution
3158 In distribution
2133 In distribution
3243 In distribution
1287 In distribution
3046 In distribution
3159 In distribution
3220 In distribution
3162 In distribution
2197 In distribution
2563 In distribution
3198 In distribution
3201 In distribution
3199 In distribution
3290 In distribution
3189 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Supra JW North America, Inc. 17

Showing 12 of 659. All products under Booth, Sun Tan

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K151370 2015-12-17

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