7LS FA7-1400J

GUDID 00031262096531

ReSculpt Micro-Current & Light Therapy

FKA DISTRIBUTING CO., LLC

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00031262096531
NIH Device Record Key5af25514-d370-4e2d-9ba7-fab8755a3109
Commercial Distribution StatusIn Commercial Distribution
Brand Name7LS
Version Model NumberFA7-1400J
Catalog NumberFA7-1400J
Company DUNS183280973
Company NameFKA DISTRIBUTING CO., LLC
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone248-863-3176
Emailcservice@7LSbeauty.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100031262096531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-02-29

On-Brand Devices [7LS]

00031262096531ReSculpt Micro-Current & Light Therapy
00031262096265ReNew Light Therapy

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