Current Body Skin Hand Perfector

GUDID 05060534510340

Glove Device- Currentbody Branded

I-SMART DEVELOPMENTS LIMITED

Cosmetic red-light phototherapy system, home-use
Primary Device ID05060534510340
NIH Device Record Key0e730736-c7db-4431-89cc-049c3cdac1f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurrent Body Skin Hand Perfector
Version Model NumberTN19S
Company DUNS223616320
Company NameI-SMART DEVELOPMENTS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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-Countertrue

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060534510340 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-31
Device Publish Date2021-05-21

Devices Manufactured by I-SMART DEVELOPMENTS LIMITED

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05060534510999 - C-Wave LED Mask for Neck & Décolleté2024-11-19 C-Wave LED Mask for Neck & Décolleté Beauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device)
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05060534510968 - SMOOTHSKIN DuoLux LED Facemask 2024-08-30 SMOOTHSKIN DuoLux LED Facemask Rebrand of V1 Facemask (TN2010)
05060534510906 - Beauty Pie C-Wave Light Facial Mask2024-06-17 Beauty Pie C-Wave Light Facial Mask- Rebranded V1 Facemask (TN2010)

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