FDA.reportPublic FDA data

Lucent IPL – handpiece

Primary DI
00754016214011
Brand
Lucent IPL – handpiece
Company
Luvo Medical Technologies Inc
Model
3134 A9999001
Published
2021-06-01
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00754016214011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754016214011007540162140117540162140110754016214011

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204046564
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754016214004Lucent IPLESM-9200IL2021-06-01
00754016214134Darwin ESK-3272LV2022-10-14
00754016214158Darwin IPL Handpiece3134 A9999001LV2022-10-14
00754016214165Darwin Diode Laser Handpiece9300-A0000101LV2022-10-14
00754016214172RF Microneedling Handpiece3245-A9900201LV2022-10-14
00754016214189Darwin RF Thermal 7600-A992022-10-14
00754016214028Bare 808ESM-9300LD2021-06-02
00754016214035BARE: 808 HANDPIECE 9300-A00001012021-06-02
10754016214124World PRPWORLDPRP2021-08-11
00754016214127World PRPWORLDPRP2021-08-11
00754016214042Bela MD+ESK-2281HD2021-06-01
00754016214059BELA MD+ AQUA HANDPIECE2225-SHP000032021-06-01
00754016214066BELA MD+ SKIN SCRUBBER HANDPIECEES00762021-06-01
00754016214073BELA MD+ Y HANDPIECE2253-A99002012021-06-01
00754016214080BELA MD+ ELECTROPORATION HANDPIECE2249-A99002012021-06-01
00754016214097BELA MD+ AQUA TIPES25862021-06-01
00754016214103BELA MD+ AQUA TIPES25872021-06-01
00754016214110BELA MD+ DIAMOND TIPES20602021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
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
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-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
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14