EOS X by Deesse Pro

GUDID 05060534510401

EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.

I-SMART DEVELOPMENTS LIMITED

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp
Primary Device ID05060534510401
NIH Device Record Keyfcb755f1-f236-42fe-998b-451082be2576
Commercial Distribution StatusIn Commercial Distribution
Brand NameEOS X by Deesse Pro
Version Model NumberTN2214
Company DUNS223616320
Company NameI-SMART DEVELOPMENTS LIMITED
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060534510401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLPOver-The-Counter Powered Light Based Laser For Acne

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-31
Device Publish Date2024-01-23

Devices Manufactured by I-SMART DEVELOPMENTS LIMITED

05060534510401 - EOS X by Deesse Pro2024-01-31EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
05060534510401 - EOS X by Deesse Pro2024-01-31 EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
05060534510685 - Luma Blemish2023-11-03 Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris
05060534510692 - Luma Revive2023-11-03 Luma Revive- Mini LED Patch to treat facial wrinkles
05060534510746 - Lightmax mini pro Eyeconic LED2023-11-03 Lightmax mini pro Eyeconic LED- Mini LED Patch to treat facial wrinkles
05060534510807 - Omnilux Blemish Eraser2023-11-03 Omnilux Blemish Eraser- Mini LED Patch to treat mild to moderate acne vulgaris
05060534510814 - Omnilux Eye Brightener2023-11-03 Omnilux Eye Brightener- Mini LED Patch to treat facial wrinkles
05060534510524 - Omnilux Men's2022-11-01 Omnilux Men's Facemask Device (Red & NIR).
05060534510494 - Boost LED Collar2022-10-27 Boost LED Collar- The Light Salon
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