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Powered Laser Surgical Instrument－Nice Station Light Based Platform

Primary DI
06970285176049
Brand
Powered Laser Surgical Instrument－Nice Station Light Based Platform
Company
Beijing Syntech Laser Co., Ltd.
Model
MLP-04
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K113018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113018000APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMBEIJING SYNTECH LASER CO., LTD.2012-12-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970285176049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970285176049069702851760496970285176049

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical frequency-doubled 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 to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528741132
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970285174281Powered Laser Surgical Instrument-Diode LaserDLH-122018-07-12
06970285176148Powered Laser Surgical Instrument APOLLO IV+ Medical PlatformMLP-102017-06-30
06970285179057Powered Laser Surgical Instrument-Trixel II CO2 LaserUFL-602017-06-29
06970285179095Powered Laser Surgical Instrument-UL CO2 LaserCFL-10U2017-06-29
06970285174168Powered Laser Surgical Instrument-Diode Laser ModelDLH-062017-06-29
06970285176018Powered Laser Surgical Instrument－APOLLO V+ Medical PlatformMLP-012017-06-30
06970285176025Powered Laser Surgical Instrument－APOLLO IV+ Medical PlatformMLP-022017-06-30
06970285179026Powered Laser Surgical Instrument-Trixel CO2 LaserCFL-102017-06-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
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08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
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08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07