ERISE Laser Handpiece

GUDID 08034108512426

ERISE Laser Handpiece is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The ERISE Laser Handpiece includes: - a connector to connect to the console - a cord where electrical cables and hydraulic tubes pass in - a plastic shell - a laser cavity - a mechanical shutter - an optical guide - an ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm). The 2940nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

DEKA M.E.L.A. SRL

Dermatological solid-state laser system
Primary Device ID08034108512426
NIH Device Record Key8850500f-b8a6-4915-bf54-e2b59c8c736c
Commercial Distribution StatusIn Commercial Distribution
Brand NameERISE Laser Handpiece
Version Model NumberE262B1
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
GS108034108512426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

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