FDA.reportPublic FDA data

SPORTARREDO

Primary DI
08030389004650
Brand
SPORTARREDO
Company
SPORTARREDO GROUP S.C.
Model
LP3 USA
Published
2020-07-22
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
K161394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161394000HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C.2017-07-06LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08030389004650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08030389004650080303890046508030389004650

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
435527116
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08030389004698SPORTARREDOBPHASE USA2023-06-09
08030389004636SPORTARREDOLP1 USA2020-07-22
08030389004643SPORTARREDOLP2 USA2020-07-22
08030389004667SPORTARREDOVEGA LUX USA2020-07-22
08030389004681SPORTARREDOHPO USA2020-07-22
08030389004704SPORTARREDOMASTERSUN 360 USA2020-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08600124614392Ultrasun Q18-4x500 MPUltrasun International B.V.LEJ2026-07-03
G1502L0023SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3100SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3101SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3160SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3185SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3810SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3818SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3822SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L3825SUNFITLight Sources, Inc.LEJ2026-06-26
G1502L4125DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L4180DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L6200DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L6216DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
G1502L6220DR.MÜLLERLight Sources, Inc.LEJ2026-06-26
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