ACDUAL applicator

GUDID 07290016540567

IPL applicator intended to be used for the treatment of acne vulgaris.

VENUS CONCEPT LTD

Light-energy skin surface treatment system applicator
Primary Device ID07290016540567
NIH Device Record Key658603b1-2c2b-4008-b374-4563ec22a1c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameACDUAL applicator
Version Model NumberAS120058
Company DUNS533127663
Company NameVENUS CONCEPT LTD
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016540451 [Primary]
GS107290016540567 [Package]
Contains: 07290016540451
Package: [1 Units]
In Commercial Distribution

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 Date2018-07-06
Device Publish Date2016-09-24

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