FDA.reportPublic FDA data

E-LIGHT LINE

Primary DI
08056389700170
Brand
E-LIGHT LINE
Company
ESPANSIONE MARKETING SPA
Model
MASK LM RED/CE
Catalog number
MASK LM RED/CE
Published
2018-06-06
Public version status
Update
Distribution status
Not 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
08056389700170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056389700170080563897001708056389700170

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
339474539
Device count
1
Serial number
true
Manufacturing date on label
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
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
08056389701351E-LIGHT LINEMASK LM RED/CE-0500MASK LM RED/CE-05002023-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16