FDA.reportPublic FDA data

KBL 7000 alpha extraSun+

Primary DI
04260489020258
Brand
KBL 7000 alpha extraSun+
Company
KBL GmbH
Model
KBL 6808 - 46-6T12/4g 1616 int us (T)
Device description
This device is an over-the-counter device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
Published
2021-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LEJBooth, Sun Tan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEJBooth, Sun TanGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151962000KBL Sunlamp Products (= Device Bundling name)Kbl AG2016-09-15LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260489020258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260489020258042604890202584260489020258

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet tanning deviceA mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341936227
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260489020425R11 Air R11-s-2848r1-1188i1 UP 122025-06-25
04260489020418KBL K11 Air (Loft)K11-s-2010A-552B UP 052024-05-15
04260489020401KBL K9S vitaSunK9S-v-52-9s-2s UP cpi 052024-03-07
04260489020357KBL K5 pureSunK5-p-38-3Hp-0 UP ep 052023-06-09
04260489020364KBL K5 extraSunK5-e-38-3HP-0 UP ep 052023-06-09
04260489020371KBL K5 hybridSunK5-h-38-3Hp-0 UP ep 052023-06-09
04260489020388KBL K9S extraSunK9S-e-52-9s-2s UP cpi 052023-06-09
04260489020395KBL K9S hybridSunK9S-h-52-9s-2s UP cpi 052023-06-09
04260489020289KBL K7 extraSunK7-e-46-4HP-2s UP cpi 052022-12-20
04260489020296KBL K7 pureSunK7-p-46-4Hp-2s UP ep 052022-12-20
04260489020302KBL K7 pureSunK7-p-46-4Hp-2s UP cpi 052022-12-20
04260489020319KBL K7 pureSunK7-p-46-4Hp-0 UP ep 052022-12-20
04260489020326KBL K7 hybridSunK7-h-46-4Hp-2s UP cpi 052022-12-20
04260489020333KBL K7S extraSunK7S-e-46-4s-2s UP cpi 052022-12-20
04260489020340KBL K7S hybridSunK7S-h-46-4s-2s UP cpi 052022-12-20
04260489020227KBL Tower Space 3000 hybridSunT3/52-1802021-08-17
04260489020173KBL 8000 alpha extraSun+KBL 7908 - 50-6T12/4g 1616 int us (T)2021-08-02
04260489020241KBL 7900 alpha extraSun+KBL 7908 - 50-6T12/4g 1616 int us2021-08-02
04260489020265KBL 5600 alpha extraSun+KBL 5600 - 42-2T12/4a - 1616 cpi u_us2021-08-02
04260489020272KBL 6800 alpha extraSun+KBL 6808 - 46-6T12/4g 1616 int us2021-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04014501005453Golden Goddess BronzerNARVA Lichtquellen GmbH + Co KG.LEJ2026-10-20
04014501005460Supra Sun VRNARVA Lichtquellen GmbH + Co KG.LEJ2026-10-20
08809909353468N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353475N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353482N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353499N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353505N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353512N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353529N/AUNILAM CO.,LTD.LEJ2026-10-16
08809909353536N/AUNILAM CO.,LTD.LEJ2026-10-16
G5103391REDIANCELight Sources, Inc.LEJ2026-10-05
G5103392REDIANCELight Sources, Inc.LEJ2026-10-05
G5103384REDIANCELight Sources, Inc.LEJ2026-10-01
G5103390REDIANCELight Sources, Inc.LEJ2026-09-30
04014501005446SUPRA VVR PRONARVA Lichtquellen GmbH + Co KG.LEJ2026-09-25
G5103385RADIANCELight Sources, Inc.LEJ2026-09-04
G5103386RADIANCELight Sources, Inc.LEJ2026-09-04
G5103387REJUVENESSENCELight Sources, Inc.LEJ2026-09-04
04014501005439Cleo AdvantageNARVA Lichtquellen GmbH + Co KG.LEJ2026-08-25
G1503382COSMETTALight Sources, Inc.LEJ2026-08-25
04014501005422Supra SunNARVA Lichtquellen GmbH + Co KG.LEJ2026-08-19
G1503230076141PURE SUNLIGHTLight Sources, Inc.LEJ2026-07-30
G1503230036110PURE SUNLIGHTLight Sources, Inc.LEJ2026-07-24
G1503210REJUVENESSENCELight Sources, Inc.LEJ2026-07-20
08600124614163Ultrasun E6Ultrasun International B.V.LEJ2026-07-03
08600124614262Ultrasun Q6-0Ultrasun International B.V.LEJ2026-07-03
08600124614279Ultrasun Q6-2 Magnum PowerUltrasun International B.V.LEJ2026-07-03
08600124614309Ultrasun Q10-0Ultrasun International B.V.LEJ2026-07-03
08600124614316Ultrasun Q10-3 Magnum PowerUltrasun International B.V.LEJ2026-07-03
08600124614378Ultrasun Q16-3Ultrasun International B.V.LEJ2026-07-03