| 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 |
| 08034108512464 - PRISMA | 2024-09-25 The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62 |
| 08034108512495 - DEKA LILY | 2024-09-25 The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via el |
| 08034108512730 - PRISMA EMS MODULE | 2024-09-25 The PRISMA EMS MODULE device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveform |
| 08034108512709 - DEKA SMARTXIDE PRO | 2024-04-17 The SmartXide PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tiss |
| 08034108512808 - SMARTXIDE TETRA PRO | 2024-04-16 The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser ener |
| 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. |
| 08034108512846 - Scar 3 PRO | 2024-04-12 The Scar 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The Scar 3 is composed of the followin |
| 08034108512655 - Elite iQ PRO | 2024-03-21 The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is define |
| 08034108512525 - AGAIN PRO | 2023-11-08 The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sou |