Doctor Smile LA8D0001.3

GUDID 08056093610284

Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. The laser kit includes a wireless foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items: 08056093610116 - Doctor smile wiser 2 08056093611106 and 08056093611090 - protective glasses 08056093611007 - Wiser tip endodontics 08056093611014 - Wiser tip periodontics 08056093611021 - Wiser tip surgery 08056093611038 - Wiser tip implant

LAMBDA SPA

Dental diode laser system

• Primary Device ID: 08056093610284
• NIH Device Record Key: 38fb9f44-55d8-4eba-bf2e-ee400f5a2491
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doctor Smile
• Version Model Number: DOCTOR SMILE WISER 2
• Catalog Number: LA8D0001.3
• 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	08056093610284 [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: 5
• Public Version Date: 2023-09-29
• Device Publish Date: 2018-01-30

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