Lasermach PRO L200001

GUDID 06972978060017

Diode Laser Therapy Systems

Wingderm Electro-Optics Ltd.

Dermatological diode laser system
Primary Device ID06972978060017
NIH Device Record Keybe4ba463-4214-41fa-b939-732ed756069f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLasermach PRO
Version Model NumberWLA-01
Catalog NumberL200001
Company DUNS554510960
Company NameWingderm Electro-Optics 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
GS106972978060017 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-19
Device Publish Date2020-11-16

On-Brand Devices [Lasermach PRO]

06972590500014WLA-01
06972978060017Diode Laser Therapy Systems

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