FDA.reportPublic FDA data

ERISE Laser Handpiece

Primary DI
08034108512426
Brand
ERISE Laser Handpiece
Company
DEKA M.E.L.A. SRL
Model
E262B1
Device description
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.
Published
2023-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202258000ERISE Laser handpieceEl.En Electronic Engineering Spa2021-04-26GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034108512426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034108512426080341085124268034108512426

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
629381096
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034108513270ONDA PROM116V1M116V12025-11-17
08034108512877TOROM136E1M136E12026-03-11
08034108513317DEKA LUXEA PLUSM117B1117B12025-12-16
08034108512679Plus HandpieceE098H12025-10-22
08034108513263body ESTIQM116H1M116H12025-09-26
08034108513218OLOM141A1M141A12025-08-27
08057017760689DEKA PHYSIQ 360M134A1M134A12023-10-11
08034108512419BioStimul HandpieceN378C12023-06-16
08034108512464PRISMAM135A12024-09-17
08034108512891MOTUS PROM130N12025-02-04
08034108512907MOTUS PRO AXM130P12025-02-04
08034108512495DEKA LILYM135B12024-09-17
08034108512730PRISMA EMS MODULEF552012024-09-17
08034108512709DEKA SMARTXIDE PROM079BI1M079R12024-04-09
08034108512808SMARTXIDE TETRA PROM118G12024-04-08
08034108512846Scar 3 PROF540A12024-04-04
08034108512655Elite iQ PROM122K1M122K12024-03-13
08034108512525AGAIN PROM126AA12023-10-31
08034108512532SYMPHONYM126AB12023-10-31
08057017760771DEKA PHYSIQ 360 EMS ModuleF53701F537012023-10-12

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08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16