Medical San

GUDID 07898672790557

The Dermatological Diode Laser (Model: Hakon Smart) is intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, long-term reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.

MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA

Dermatological diode laser system

• Primary Device ID: 07898672790557
• NIH Device Record Key: 3fefb60a-fb53-4cab-9a3b-d8ae702f1cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medical San
• Version Model Number: Hakon Smart
• Company DUNS: 826828108
• Company Name: MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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	07898672790557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231901

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: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [Medical San]

• 07898672790557: The Dermatological Diode Laser (Model: Hakon Smart) is intended for the removal, permanent reduc
• 07898672790311: The Dermatological Diode Laser (Model: Hakon) is intended for the removal, permanent reduction o