FDA.reportPublic FDA data

KBL P9 hybridSun

Primary DI
04260489020166
Brand
KBL P9 hybridSun
Company
KBL GmbH
Model
P9 - 50h/4gx 1616 cpi us (T)
Device description
This device is an over-the-counter tanning 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
2020-06-03
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
K191881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191881000KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbH2019-10-28LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260489020166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260489020166042604890201664260489020166

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
04260489020258KBL 7000 alpha extraSun+KBL 6808 - 46-6T12/4g 1616 int us (T)2021-08-02
04260489020265KBL 5600 alpha extraSun+KBL 5600 - 42-2T12/4a - 1616 cpi u_us2021-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5102226NEW TECHNOLOGYLight Sources, Inc.LEJ2026-05-19
G51017010RENUVATANLight Sources, Inc.LEJ2026-05-12
G5101908RENUVATANLight Sources, Inc.LEJ2026-05-12
G5103370RENUVATANLight Sources, Inc.LEJ2026-05-12
G5100821RENUVATANLight Sources, Inc.LEJ2026-05-04
G5100760RENUVATANLight Sources, Inc.LEJ2026-04-29
G5103222RENUVATANLight Sources, Inc.LEJ2026-04-29
G5103137RENUVATANLight Sources, Inc.LEJ2026-04-27
G5103178RENUVATANLight Sources, Inc.LEJ2026-04-22
G1502386VIP PREMIERLight Sources, Inc.LEJ2026-04-20
G1503372GENESISLight Sources, Inc.LEJ2026-04-13
G5101318RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101586RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101915RENUVATANLight Sources, Inc.LEJ2026-04-10
G5102274RENUVATANLight Sources, Inc.LEJ2026-04-10
G5102701RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103119RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103244RENUVATANLight Sources, Inc.LEJ2026-04-10
G5103269RENUVATANLight Sources, Inc.LEJ2026-04-10
G5101180RENUVATANLight Sources, Inc.LEJ2026-04-02
G5101450RENUVATANLight Sources, Inc.LEJ2026-04-02
G5102700RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103133RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103356RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103358RENUVATANLight Sources, Inc.LEJ2026-04-02
G5103359RENUVATANLight Sources, Inc.LEJ2026-04-02
G5102275RENUVATANLight Sources, Inc.LEJ2026-03-30
G1501969BRILLIANCE ACTIVE BRONZERLight Sources, Inc.LEJ2026-03-27
G619370140SUPRAJW NORTH AMERICA, INC.LEJ2026-01-01
G619242500COSMEDICOJW NORTH AMERICA, INC.LEJ2025-12-01