Apilux 01-7112

GUDID 00686209171125

Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented Lesions, Light Hair Removal, Dark HairRemoval

Dectro International

Multi-modality skin surface treatment system
Primary Device ID00686209171125
NIH Device Record Key6e2ac422-8a88-4ade-b65a-fb1e6981bee9
Commercial Distribution StatusIn Commercial Distribution
Brand NameApilux
Version Model NumberSmartPro II
Catalog Number01-7112
Company DUNS246237945
Company NameDectro International
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100686209171125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-10-02
Device Publish Date2018-05-22

On-Brand Devices [Apilux]

06862090171121Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented Lesions, Light Ha
06862090171022Intense Pulsed Ligh (ILP) for Light Hair Removal abd Dark Hair Removal
00686209171125Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented Lesions, Light Ha
00686209171026Intense Pulsed Ligh (ILP) for Light Hair Removal abd Dark Hair Removal
00686209192205Intense Pulsed Light unit (IPL) 220Vac
00686209191109Intense Pulsed Light unit (IPL) 120Vac

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