Doctor Smile LAFIO006.3

GUDID 08056093611083

LAMBDA SPA

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 08056093611083
• NIH Device Record Key: d16ffff9-a94c-42f6-b550-40d51acf8a89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Doctor Smile
• Version Model Number: Fiber optic
• Catalog Number: LAFIO006.3
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	08056093611083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091562

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

[08056093611083]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• 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