LightMed

GUDID 04719882550010

LightMed Dental Laser System is intended to assist during dental procedures performed in oral and maxillofacial surgery and dentistry. The Erbium YAG laser is indicated for a variety of hard tissue, soft tissue and bone applications. It is also indicated for incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.

LIGHTMED DENTAL TECHNOLOGY CORPORATION

Dental solid-state laser system

• Primary Device ID: 04719882550010
• NIH Device Record Key: bfb2ba0a-0041-40fa-b26c-38da88e5fe6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightMed
• Version Model Number: Saphhire
• Company DUNS: 656103679
• Company Name: LIGHTMED DENTAL TECHNOLOGY CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719882550010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170073

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

[04719882550010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-29
• Device Publish Date: 2021-03-20

On-Brand Devices [LightMed]

• 04719882550010: LightMed Dental Laser System is intended to assist during dental procedures performed in oral an
• 04719882550034: SA-108-A2