ESPADA 2 Plus

GUDID 07350120791757

ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild to moderate inflammatory acne on the facial area

Foreo AB

Blue-light phototherapy lamp, home-use
Primary Device ID07350120791757
NIH Device Record Keyc9e3f904-ffc3-4091-911e-5c808d517dde
Commercial Distribution StatusIn Commercial Distribution
Brand NameESPADA 2 Plus
Version Model NumberLavender
Company DUNS352394143
Company NameForeo AB
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 Datetrue
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
GS107350120791757 [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 Date2024-02-28
Device Publish Date2024-02-20

On-Brand Devices [ESPADA 2 Plus]

07350120791764ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild
07350120791757ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild

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