Doctor Diode Laser LA3D0001.3

GUDID 08056093610109

Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: – 08056093610024 Wiser Laser - 08056093611090 or 08056093611106 protective glasses - 08056093611120 and/or 08056093611137 handpieces - 08056093611113 and/or 08056093611007 and/or 08056093611045 and/or 08056093611038 and/or 08056093611014 and/or 08056093611021 tips

LAMBDA SPA

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system
Primary Device ID08056093610109
NIH Device Record Keyb4bb405e-52b7-450a-a70a-af64c0ec066c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDoctor Diode Laser
Version Model NumberDoctor Smile
Catalog NumberLA3D0001.3
Company DUNS428482616
Company NameLAMBDA SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS108056093610109 [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 Number4
Public Version Date2021-04-07
Device Publish Date2016-12-01

On-Brand Devices [Doctor Diode Laser]

18056093611110Tip ENT
18056093611042Doctor Diode Laser/Optical Tip LATHE402.4 (Doctor Smile - Wiser Tip) is used in therapy applica
18056093611035Doctor Diode Laser/ Optical Tip LATIM302.4 (Doctor Smile - Wiser Tip) is used in implants appli
18056093611028Doctor Diode Laser/ Optical Tip LATSU302.4 (Doctor Smile - Wiser Tip) is used in surgery applic
18056093611011Doctor Diode Laser / Optical Tip LATPA402.4 (Doctor Smile - Wiser Tip) is used in periodontics
08056093610109Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is i
08056093610024Doctor Diode Laser Family including Doctor Smile Wiser (LA3D0001.3) is available with power of 1
08056093611007Doctor Diode Laser/ Optical tip LATEN202.4 (Doctor Smile Wiser Tip) is suitable in endodontics
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