DEVICE: 810nm 200mW Standard Tip (05060494130220)
Device Identifier (DI) Information
810nm 200mW Standard Tip
2.3
In Commercial Distribution
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution
THOR PHOTOMEDICINE LIMITED
S2092 810nm 200mW Standard Tip
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
45688 | Red-light phototherapy unit, professional |
An electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K033923 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2b18a259-6c77-4eed-b409-388bdd9a2e51
December 08, 2022
5
September 20, 2016
December 08, 2022
5
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined