univeiLED (Priori) 111A

GUDID 05060534510159

V1 facemask- Priori/ univeiLED Branded

I-SMART DEVELOPMENTS LIMITED

Cosmetic red-light phototherapy system, home-use

Primary Device ID	05060534510159
NIH Device Record Key	e3cfc49c-8a9d-4fce-9791-328451a61170
Commercial Distribution Status	In Commercial Distribution
Brand Name	univeiLED (Priori)
Version Model Number	TN2010
Catalog Number	111A
Company DUNS	223616320
Company Name	I-SMART DEVELOPMENTS LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Operating and Storage Conditions

Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between -5 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060534510159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191629

FDA Product Code

OHS	Light Based Over The Counter Wrinkle Reduction

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-05-13
Device Publish Date	2021-05-05

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