FDA.reportPublic FDA data

Original Hanau

Primary DI
14054657500270
Brand
Original Hanau
Company
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Model
Strahler OH M 600 EF
Catalog number
8002 3108
Device description
UV - Tanning lamp
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
14054657500270PackageGS11In Commercial Distribution
54054657600275PackageGS1100In Commercial Distribution
04054657500273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1405465750027014054657500270
5405465760027554054657600275
04054657500273040546575002734054657500273

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
G5103178RENUVATANLight Sources, Inc.LEJ2026-04-22