Doctor Smile LA5D0001.2

GUDID 08056093610093

Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: 08056093610062 – B-980 Laser 08056093611090 - protective glasses 08056093611120 and/or 08056093611137 handpieces 08056093611083 and/or 08056093611052 and/or 08056093611069 and/or 08056093611076 fibers

LAMBDA SPA

General/multiple surgical diode laser system

• Primary Device ID: 08056093610093
• NIH Device Record Key: 4759973c-9720-4237-ac87-0eca85162c43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doctor Smile
• Version Model Number: Doctor Smile B-980
• Catalog Number: LA5D0001.2
• 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	08056093610093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091562

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: 2016-12-15

On-Brand Devices [Doctor Smile]

• 08056093611120: Doctor Smile handpieces (LAFIO0025.1) are designed for a fast and easy connection to the laser,
• 08056093611083: Fiber optic
• 08056093611076: Fiber optic
• 08056093611069: Fiber optic
• 08056093611052: Fiber optic
• 08056093610093: Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intende
• 08056093610062: Doctor Smile B-980 Laser (Doctor Smile D5 980 nm) is a standard diode medical laser with 980 nm
• 08056093611137: Doctor smile handpieces are designed for a fast and easy connection to the laser, for both denta
• 08056093610284: Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is inten