Apolomed

GUDID 06970745912323

Fiber Laser Treatment Systems

Shanghai Apolo Medical Technology Co.,Ltd

Dermatological dye laser system
Primary Device ID06970745912323
NIH Device Record Keybd2b9317-cbb6-4c47-91c0-d39d2d7efd41
Commercial Distribution Discontinuation2030-07-20
Commercial Distribution StatusIn Commercial Distribution
Brand NameApolomed
Version Model NumberHS-232
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106970745912323 [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 Date2025-07-29
Device Publish Date2025-07-21

On-Brand Devices [Apolomed]

06970745912330Fiber Laser Treatment Systems
06970745912323Fiber Laser Treatment Systems

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