FDA.reportPublic FDA data

Phoenix CO2

Primary DI
00860564000324
Brand
Phoenix CO2
Company
ROHRER AESTHETICS, LLC
Model
Phoenix
Device description
The equipmnent is used for- human tissue vaporization. coagulation in dermatology and plasticsurgery, general surgery, gynecology, podiatry, dental and otolaryngology.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860564000324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860564000324008605640003248605640003240860564000324

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological carbon dioxide laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083701842
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860564000317Spectrum Laser/IPLSpectrum2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800291821191eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821207eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821214eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821221eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821238eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821245eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821252eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821269eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821276eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821283eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821290eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821306eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821313eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821320eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
08800291821337eCO2 3DCynosure Lutronic Technology CorporationONG2026-04-15
06974077940023MLKJWeifang Mingliang Electronics Co., Ltd.ONG2025-09-17
06970745912323ApolomedShanghai Apolo Medical Technology Co.,LtdONG2025-07-21
06970745912330ApolomedShanghai Apolo Medical Technology Co.,LtdONG2025-07-21
08057622080004MTONE EVOM & T SRLONG2025-04-15
08057622080011MTONE EVOM & T SRLONG2025-04-15
08057622080028MT ONEM & T SRLONG2025-04-15
08057622080035MT ONEM & T SRLONG2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONG2025-04-15
G7433426Smooth Beauty LaserTria Laser IncONG2025-03-07
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08800016903973Fraxis HandpieceCLASSYS Inc.ONG2024-10-30