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

• Primary Device ID: 08056093610109
• NIH Device Record Key: b4bb405e-52b7-450a-a70a-af64c0ec066c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doctor Diode Laser
• Version Model Number: Doctor Smile
• Catalog Number: LA3D0001.3
• Company DUNS: 428482616
• Company Name: LAMBDA SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056093610109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102036

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-12-01

On-Brand Devices [Doctor Diode Laser]

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