| Primary Device ID | 08034108512846 |
| NIH Device Record Key | 8cff7721-ab89-4dfd-b57c-a7cbd5f8d877 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scar 3 PRO |
| Version Model Number | F540A1 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08034108512846 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
[08034108512846]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-12 |
| Device Publish Date | 2024-04-04 |
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| 08034108512846 - Scar 3 PRO | 2024-04-12The 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. |
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| 08034108512532 - SYMPHONY | 2023-11-08 The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser outpu |
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| 08057017760689 - DEKA PHYSIQ 360 | 2023-10-19 The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient ( |