FDA.reportPublic FDA data

Apilux

Primary DI
06862090171022
Brand
Apilux
Company
Dectro International
Model
SmartPur II
Catalog number
01-7102
Device description
Intense Pulsed Ligh (ILP) for Light Hair Removal abd Dark Hair Removal
Published
2018-05-22
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

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
06862090171022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06862090171022068620901710226862090171022

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
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