FDA.reportPublic FDA data

Original Hanau

Primary DI
14054657500331
Brand
Original Hanau
Company
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Model
Strahler OH N 800 SF
Catalog number
8001 5355
Device description
UV - Tanning lamp, Accession # 0631196-001 Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com Manufacturer: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K151674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151674000Ultraviolet Sun Tanning LampG.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh2015-10-20LEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14054657500645PackageGS11In Commercial Distribution
54054657600336PackageGS1100In Commercial Distribution
54054657600640PackageGS1100In Commercial Distribution
14054657500331PreviousGS10
04054657500648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405465750064514054657500645
5405465760033654054657600336
5405465760064054054657600640
1405465750033114054657500331
04054657500648040546575006484054657500648

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4961814902316info@original-hanau.com

Regulatory Flags#

DUNS number
312827900
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054657500228Original HanauStrahler OH M 400 SF4500 64072016-12-13
04054657500235Original HanauStrahler OH M 50/100 EF8002 67502016-12-13
04054657500259Original HanauStrahler OH M 500 SF4500 64092017-02-28
04054657500273Original HanauStrahler OH M 600 EF8002 31082017-02-28
04054657500549Original HanauStrahler OH N 70/120 EF8000 85992016-12-13
04054657500556CosmedicoStrahler SUPRA Q-250 BPR8004 13102017-02-28
04054657500587Original HanauStrahler OH C 460 SF5606 98992017-02-28
04054657500594Original HanauStrahler OH M 60/80 EF8002 15172017-02-28
04054657500600Original HanauStrahler OH N 24/50 EF4500 65442017-02-28
04054657500617Original HanauStrahler OH C 400 EF8000 98982017-02-28
04054657500624Original HanauStrahler OH N 50/100 EF+4500 64112017-02-28
04054657500631Original HanauStrahler Varius EF vst8002 65002017-02-28
04054657500648Original HanauStrahler OH N 800 SF8001 53552017-02-28
04054657500655Original HanauStrahler OH C 560 SF8000 44572017-02-28
04054657500037MegalineStrahler BQ 460 SF8002 61142017-02-28
04054657500051JKStrahler JK 30/60 EF8003 09182017-02-28
04054657500198Original HanauStrahler OH C 561 LF8000 44562017-02-28
54054657600220Original HanauStrahler OH M 400 SF4500 64072016-12-13
54054657600237Original HanauStrahler OH M 50/100 EF8002 67502016-12-13
14054657500256Original HanauStrahler OH M 500 SF4500 64092017-02-28

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