FDA.reportPublic FDA data

Powered Laser Surgical Instrument-UL CO2 Laser

Primary DI
06970285179095
Brand
Powered Laser Surgical Instrument-UL CO2 Laser
Company
Beijing Syntech Laser Co., Ltd.
Model
CFL-10U
Published
2017-06-29
Public version status
Update
Distribution status
Not 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
K110434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110434000TRIXEL CO2 LASERBEIJING SYNTECH LASER CO., LTD.2011-04-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970285179095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970285179095069702851790956970285179095

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state/carbon dioxide laser systemA mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology.

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
06970285176018Powered Laser Surgical Instrument APOLLO V+ Medical PlatformMLP-012017-06-30
06970285176025Powered Laser Surgical Instrument APOLLO IV+ Medical PlatformMLP-022017-06-30
06970285176049Powered Laser Surgical Instrument Nice Station Light Based PlatformMLP-042017-06-30
06970285179026Powered Laser Surgical Instrument Trixel CO2 LaserCFL-102017-06-29
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
06970285174168Powered Laser Surgical Instrument-Diode Laser ModelDLH-062017-06-29

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