Silk'n 7290019840053

GUDID 27290019840057

LED Light Therapy Mask

SILKN BEAUTY LTD

Blue/red/infrared phototherapy lamp

Primary Device ID	27290019840057
NIH Device Record Key	dd1dfae2-73da-43a7-a941-fa6f5c19d716
Commercial Distribution Status	In Commercial Distribution
Brand Name	Silk'n
Version Model Number	FM-03
Catalog Number	7290019840053
Company DUNS	625893101
Company Name	SILKN BEAUTY LTD
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	false
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 -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 80 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019840053 [Direct Marking]
GS1	17290019840050 [Primary]
GS1	27290019840057 [Package] Contains: 17290019840050 Package: OUTER PACKAGE [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223544

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	2023-12-04
Device Publish Date	2023-11-26