LightMed Sapphire

GUDID 04719882550034

LIGHTMED DENTAL TECHNOLOGY CORPORATION

Dental solid-state laser system

• Primary Device ID: 04719882550034
• NIH Device Record Key: a1c4b488-6952-451e-a3d4-0269a77b88e9
• Commercial Distribution Discontinuation: 2022-08-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightMed
• Version Model Number: SA-108-A2
• Catalog Number: Sapphire
• 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: true
• 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	04719882550034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170073

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [LightMed]

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