FDA.reportPublic FDA data

Apilux

Primary DI
00686209191109
Brand
Apilux
Company
Dectro International
Model
APL3G 120V
Catalog number
01-9110
Device description
Intense Pulsed Light unit (IPL) 120Vac
Published
2021-05-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00686209191109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00686209191109006862091911096862091911090686209191109

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] 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 a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246237945
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00686209051212ApilusElectropil01-12102026-05-12
00686209051014Pro-TecStainless Steel F105-01012024-10-09
00686209051021Pro-TecStainless Steel F205-01022024-10-09
00686209051038Pro-TecStainless Steel F305-01032024-10-09
00686209051045Pro-TecStainless Steel F405-01042024-10-09
00686209051052Pro-TecStainless Steel F505-01052024-10-09
00686209052011Pro-TecIsoGard F105-02012024-10-09
00686209052028Pro-TecIsoGard F205-02022024-10-09
00686209052035Pro-TecIsoGard F305-02032024-10-09
00686209052042Pro-TecIsoGard F405-02042024-10-09
00686209052059Pro-TecIsoGard F505-02052024-10-09
00686209052110Pro-TecIsoBlend F105-02112024-10-09
00686209052127Pro-TecIsoBlend F205-02122024-10-09
00686209052134Pro-TecIsoBlend F305-02132024-10-09
00686209052141Pro-TecIsoBlend F405-02142024-10-09
00686209052158Pro-TecIsoBlend F505-02152024-10-09
00686209100903ApilusCLEO FLASH 12801-0090US2024-05-23
00686209100910ApilusCLEO BLEND 25601-0091US 2024-05-23
00686209101115ApilusJunior01-0111US2024-05-23
00686209106004Apilusxcell Pur01-0600US2024-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970453310022MONALIZABeijing Sincoheren S&T Development Co.,Ltd.ONF2026-09-24
06970453310039MONALIZABeijing Sincoheren S&T Development Co.,Ltd.ONF2026-09-24
06973011720158Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., LtdONF2026-08-07
07290019840428Silk'nSilkn Beauty Ltd.ONF2026-05-06
00810060831359Venus Versa PROVenus Concept Inc.ONF2026-04-15
06979922960010MICOWEYMicowey Medical Equipment (Guangxi) Co., LTDONF2026-04-08
00850055552555InBellaMax SystemInbella Medical IncONF2026-03-25
06975617994025MULTIFUNCTIONAL SERIESBEIJING HONKON TECHNOLOGIES CO., LTD.ONF2026-03-23
00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
00860009525146MediLightMEDICREATIONS LLCONF2026-02-11
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLONF2025-12-16
07290117772645Black Stellar XPL HPLUMENIS BE LTDONF2025-09-08
07290117772652Stellar XPL Module KitLUMENIS BE LTDONF2025-09-08
07290016633313Plus ApplicatorINMODE M.D LTDONF2025-07-27
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
06974851083014BVLASERNanjing Bestview Laser S&T Co.,Ltd.ONF2024-11-27
06976573489105BilensShanghai Bele Medical Technology Co., Ltd.ONF2024-11-24
07290016681093iProEliteFORMATK SYSTEMS LTDONF2024-10-15
06928258000891GSDShenzhen GSD Tech Co., Ltd.ONF2024-09-30
06977620360019ZHEONEHebei Zhemai Technology Co., Ltd.ONF2024-09-19
08034108512464PRISMADEKA M.E.L.A. SRLONF2024-09-17
07290019863144Lumecca PeakINMODE M.D LTDONF2024-08-15
07290019863151Lumecca PeakINMODE M.D LTDONF2024-08-15
00850033906004XLase PlusBIOTEC ITALIA SRLONF2024-07-29