Apolomed

GUDID 06970745914112

CO2 Laser Therapy System

Shanghai Apolo Medical Technology Co., Ltd.

General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system General/multiple surgical carbon dioxide laser system
Primary Device ID06970745914112
NIH Device Record Keya7842337-f9dd-4434-bd3d-8a2f721f9b29
Commercial Distribution StatusIn Commercial Distribution
Brand NameApolomed
Version Model NumberHS-411
Company DUNS529854247
Company NameShanghai Apolo Medical Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]
GS106970745914112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

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06970745912903EO Q-Switched Nd: YAG Laser Systems
06970745918196Diode Laser Therapy Device
06970745918189Diode Laser Therapy Device
06970745918172Diode Laser Therapy Device
06970745918165Diode Laser Therapy Device
06970745918127Diode Laser Therapy Device
06970745918110Diode Laser Therapy Device
06970745918103Diode Laser Therapy Device
06970745916604IPL (Intense Pulsed Light) Treatment Systems
06970745916512IPL (Intense Pulsed Light) Treatment Systems
06970745916208IPL (Intense Pulsed Light) Treatment Systems
06970745913108IPL (Intense Pulsed Light) Treatment Systems
06970745913016IPL (Intense Pulsed Light) Treatment Systems
06970745912989Picosecond Nd: YAG Laser System
06970745914129CO2 Laser Therapy System
06970745914112CO2 Laser Therapy System

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