FDA.report

LASEMAR

Primary DI
08054188640482
Brand
LASEMAR
Company
EUFOTON SRL
Model
1000
Device description
Laser surgical instrument
Published
2017-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K092860000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K092860000LASEMAR 800, 1000, 1500Eufoton S.R.L.2010-07-16GEX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08054188640482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08054188640482080541886404828054188640482

GMDN Terms

TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods

Method

Regulatory Flags

DUNS number
514355564
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08054188640475LASEMAR8002017-12-11
08054188640499LASEMAR15002017-12-11

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