e-light I-US 230020148

GUDID 07898616351400

Laser system for therapy

DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA

Red/infrared light phototherapy unit

• Primary Device ID: 07898616351400
• NIH Device Record Key: a8ba8a35-f3b0-463d-bd7d-b56c29102fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-light I-US
• Version Model Number: 230020148
• Catalog Number: 230020148
• Company DUNS: 904563269
• Company Name: DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	07898616351400 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA

• 07898616351431 - OstomyGel: 2025-05-06 Ostomy accessory
• 07898616351400 - e-light I-US: 2025-03-13Laser system for therapy
• 07898616351400 - e-light I-US: 2025-03-13 Laser system for therapy
• 07898616351417 - e-light B-US: 2025-03-13 Heat source for bleaching teeth
• 07898616351424 - e-light V-US: 2025-03-13 Heat source for bleaching teeth
• 07898616351127 - Therapy EC (FDA): 2025-01-29 Laser system for therapy
• 07898616351134 - Therapy XT (FDA): 2025-01-29 Laser system for therapy