Diode Laser Therapy System

GUDID 06973011720011

Sanhe Leifeishi Electronic Product Co.,Ltd.

Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system Dermatological diode laser system
Primary Device ID06973011720011
NIH Device Record Keyd16096da-7e54-4290-8cc0-0fa270c411d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode Laser Therapy System
Version Model NumberLFS-K8
Company DUNS550747317
Company NameSanhe Leifeishi Electronic Product 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973011720011 [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 Date2020-05-06
Device Publish Date2020-04-28

On-Brand Devices [Diode Laser Therapy System]

06973011720035LFS-K2
06973011720028LFS-K5
06973011720011LFS-K8

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