Who else makes this device?

Name: KBL 6800 alpha extraSun+
Brand: KBL 6800 alpha extraSun+

General & Plastic Surgery › SurgicalBooth, Sun Tan

KBL 6800 Alpha Extrasun+

This device is an over-the-counter device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning the human skin of an adult person.

Registry build 21.09.26

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.

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 KBL 6800 alpha extraSun+
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	2021-08-02

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for KBL 6800 alpha extraSun+
Catalogue number	Size	Status
KBL 6808 – 46-6T12/4g 1616 int us		In distribution

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
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.