Scar 3 PRO

GUDID 08034108512846

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 ID08034108512846
NIH Device Record Key8cff7721-ab89-4dfd-b57c-a7cbd5f8d877
Commercial Distribution StatusIn Commercial Distribution
Brand NameScar 3 PRO
Version Model NumberF540A1
Company DUNS629381096
Company NameDEKA M.E.L.A. SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108034108512846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-12
Device Publish Date2024-04-04

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