FDA.reportPublic FDA data

E-LIGHT LINE

Primary DI
08056389700088
Brand
E-LIGHT LINE
Company
ESPANSIONE MARKETING SPA
Model
LED MASKH-05
Catalog number
LED MASK H-05
Published
2019-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092734000E-LIGHT LINEEspansione Marketing S.P.A2010-09-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056389700088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056389700088080563897000888056389700088

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Regulatory Flags#

DUNS number
339474539
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056389701115YOUNG AGAINYOUNG AGAIN2026-04-30
08056389701122EPI-C PLUSEPI-C PLUSEPI-C PLUS2026-04-30
08056389700194E-LIGHT LINEMASK LM YELLOW/CEMASK LM YELLOW/CE2018-06-06
08056389700019E-LIGHT LINEE-LIGHT DEVICEE-LIGHT DEVICE2019-11-21
08056389700095E-LIGHT LINELED MASKH-20LED MASK H-202019-09-03
08056389700118E-LIGHT LINELED MASKLED MASK2018-06-06
08056389700132E-LIGHT LINELED MASK/RED-05LED MASK/RED-052018-06-06
08056389700156E-LIGHT LINELED MASK/RED-20LED MASK/RED-202018-06-06
08056389700170E-LIGHT LINEMASK LM RED/CEMASK LM RED/CE2018-06-06
08056389700187E-LIGHT LINEMASK LM BLUE/CEMASK LM BLUE/CE2018-06-06
08056389700378MY MASK-EMY MASK-E/PSMY MASK-E/PS2020-05-25
08056389700385MY MASK-EMY MASK-E/M250MY MASK-E/M2502020-05-25
08056389700392MY MASK-EMY MASK-E/M500MY MASK-E/M5002020-05-25
08056389700408MY MASK-EMY MASK-E/M2000MY MASK-E/M20002020-05-25
08056389700217E-LIGHT LINELED MASK/BLUE-05LED MASK/BLUE-052019-05-24
08056389701009E-LIGHT LINEIPL LAMP-390 IPL LAMP-3902024-05-14
08056389701016E-LIGHT LINEIPL LAMP-550 IPL LAMP-5502024-05-14
08056389701023E-LIGHT LINEIPL LAMP-LSIPL LAMP-LS2024-05-14
08056389701030E-LIGHT LINEIPL LAMP-DSIPL LAMP-DS2024-05-14
08056389701047E-LIGHT LINEEPI-C PLUSEPI-C PLUS2024-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173391882Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391912Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391943Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391196Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2020-06-09
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390786Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15