Diode laser therapy system

GUDID 06976233581002

Diode laser therapy system

Hebei Newangel Technology Co., Ltd.

Dermatological diode laser system
Primary Device ID06976233581002
NIH Device Record Key65bec7a1-750c-41b5-b0cd-be9365ed83d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode laser therapy system
Version Model Numberltmax
Company DUNS408311018
Company NameHebei Newangel Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106976233581002 [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 Date2023-04-24
Device Publish Date2023-04-14

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