DEVICE: Lunula (00858985006056)

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Device Identifier (DI) Information

Lunula
FFS
FFS
ERCHONIA CORPORATION, LLC
00858985006056
GS1
1
MEDICAL - Floor Model Low Level Laser - 2 diodes 635nm & 405nm - IFU Reduction Onychomycosis
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Nail laser phototherapy unit A portable, mains electricity (AC-powered), laser-emitting device intended to treat nail fungal infection (onychomycosis) using low-level laser treatment (LLLT). It typically consists of an electronic unit with a digital display and a treatment platform where the foot/hand is placed to receive LLLT; it typically includes protective eyewear. It is intended to be used by a healthcare provider in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
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Sterilization

No
No
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 Status

In Commercial Distribution
September 24, 2016

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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

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
(888) 242-0571
info@erchonia.com
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