DEVICE: l.a.b. Light Activated Beauty® (B347ACDUO0)

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Device Record History
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Device Identifier (DI) Information
l.a.b. Light Activated Beauty®
ACDUO
Not in Commercial Distribution

LED TECHNOLOGIES INC
B347ACDUO0
HIBCC
June 01, 2024
2
197386191 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
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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
OLP Over-The-Counter Powered Light Based Laser For Acne
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
ee07579a-2755-44b2-a4d5-38a42ae583bf
December 06, 2024
2
March 13, 2024
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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
B347ACDUO1 96 B347ACDUO0 2024-06-01 Not in Commercial Distribution
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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: B347ACPOD02 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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