Apolomed

GUDID 06970745917700

Phototherapy Systems

Shanghai Apolo Medical Technology Co., Ltd.

Skin photodynamic therapy/phototherapy lamp
Primary Device ID06970745917700
NIH Device Record Key1cfc0ff3-0d81-4d5f-b19d-6d50606b9740
Commercial Distribution Discontinuation2025-01-05
Commercial Distribution StatusIn Commercial Distribution
Brand NameApolomed
Version Model NumberHS-770
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106970745917700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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 Date2020-01-14
Device Publish Date2020-01-06

On-Brand Devices [Apolomed]

06970745918905Diode Laser Therapy Devices
06970745917700Phototherapy Systems
06970745916505IPL (Intense Pulsed Light) Treatment Systems
06970745913009IPL(Intense Pulsed Light) Treatment Systems
06970745912910EO Q-Switched Nd:YAG Laser Systems
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
06970745918516Diode Laser Body Sculpture System
06970745919001Platform Treatment System
06970745912309Fiber Laser Treatment System
06970745915911Electromagnetic Stimulation Systems
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