DEVICE: Omnilux CLEAR (05060534510234)

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Device Record History
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Device Identifier (DI) Information
Omnilux CLEAR
TN2112
In Commercial Distribution
135-OC
I-SMART DEVELOPMENTS LIMITED
05060534510234
GS1

1
223616320 *Terms of Use
Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded
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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?
62116 Red/blue light phototherapy unit
A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OLP Over-The-Counter Powered Light Based Laser For Acne
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K210948 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 Temperature: between -5 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
48a154a0-b93d-416c-bc38-b09e1a0a14bc
July 13, 2021
1
July 05, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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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
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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