Apolomed

GUDID 06970745912309

Fiber Laser Treatment System

Shanghai Apolo Medical Technology Co., Ltd.

Dermatological dye laser system
Primary Device ID06970745912309
NIH Device Record Key1d516fc5-eca2-4575-8f63-1fa1f2fef299
Commercial Distribution Discontinuation2027-11-29
Commercial Distribution StatusIn Commercial Distribution
Brand NameApolomed
Version Model NumberHS-230
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106970745912309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

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06970745918172Diode Laser Therapy Device
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06970745918127Diode Laser Therapy Device
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06970745916512IPL (Intense Pulsed Light) Treatment Systems
06970745916208IPL (Intense Pulsed Light) Treatment Systems
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06970745913016IPL (Intense Pulsed Light) Treatment Systems
06970745912989Picosecond Nd: YAG Laser System
06970745914129CO2 Laser Therapy System
06970745914112CO2 Laser Therapy System
06970745918516Diode Laser Body Sculpture System
06970745919001Platform Treatment System
06970745912309Fiber Laser Treatment System
06970745915911Electromagnetic Stimulation Systems
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