DEVICE: N/A (06974020961037)

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Device Record History
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Device Identifier (DI) Information
N/A
FM-02
In Commercial Distribution

Guangdong Newdermo Biotech Co.,Ltd.
06974020961037
GS1

1
403370499 *Terms of Use
FM-02 ; LED light therapy mask
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62202 Blue/red/infrared phototherapy lamp
A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OHS Light Based Over The Counter Wrinkle Reduction
OLP Over-The-Counter Powered Light Based Laser For Acne
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K223544 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
c3bb308a-1483-4809-8225-c859b1d07a06
August 05, 2024
1
July 28, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
16974020961034 12 06974020961037 In Commercial Distribution outer packing
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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