Scar 3

GUDID 08034108512082

The Scar 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The Scar 3 is composed of the following components: - HiScan Scar 3 head - HiScan Scar 3 cable Laser emission parameters are selected through the GUI of DEKA laser device to whom the scanner is connected. Shape and size of the scanning area may also be selected by using the three keys on the scanning head.

DEKA M.E.L.A. SRL

Skin laser scanner

• Primary Device ID: 08034108512082
• NIH Device Record Key: 7d77b3b8-00de-4e39-af36-fe4354343f98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scar 3
• Version Model Number: F397B1
• Company DUNS: 629381096
• Company Name: DEKA M.E.L.A. SRL
• 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: 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	08034108512082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231309

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

[08034108512082]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [Scar 3 ]

• 08034108511399: The SCAR 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The SC
• 08034108512082: The Scar 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The Sc