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 Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner Skin laser scanner 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