DEVICE: SpectraLite (B347BA5670100)

Device Identifier (DI) Information

SpectraLite
BA567010
In Commercial Distribution

LED TECHNOLOGIES INC
B347BA5670100
HIBCC

1
197386191 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blue/red/infrared phototherapy lamp A portable mains electricity (AC-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, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). It is normally available [non-prescription] over-the-counter (OTC) for use by the patient in the home or by a healthcare professional in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
OHS Light Based Over The Counter Wrinkle Reduction
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

7b5ac0b6-f47b-4d68-83cb-b4f37a2556b3
March 29, 2018
2
January 23, 2017
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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
B347BA5670102 8 B347BA5670101 In Commercial Distribution
B347BA5670101 3 B347BA5670100 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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