DEVICE: Phoenix CO2 (00860564000324)

Device Identifier (DI) Information

Phoenix CO2
Phoenix
In Commercial Distribution

ROHRER AESTHETICS, LLC
00860564000324
GS1

1
083701842 *Terms of Use
The equipmnent is used for- human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otolaryngology.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Dermatological carbon dioxide laser system A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam [i.e., not considered low-level laser therapy (LLLT)], intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.
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FDA Product Code

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Product Code Product Code Name
ONG Powered Laser Surgical Instrument With Microbeam\Fractional Output
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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

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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

0c69c411-653c-4fc7-8ebc-df0b23dda4af
March 29, 2018
2
September 22, 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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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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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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