FDA.reportPublic FDA data

Powered Laser Surgical Instrument APOLLO V+ Medical Platform

Primary DI
06970285176018
Brand
Powered Laser Surgical Instrument APOLLO V+ Medical Platform
Company
Beijing Syntech Laser Co., Ltd.
Model
MLP-01
Published
2017-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970285176018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970285176018069702851760186970285176018

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.

Regulatory Flags#

DUNS number
528741132
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06970285179095Powered Laser Surgical Instrument-UL CO2 LaserCFL-10U2017-06-29
06970285174168Powered Laser Surgical Instrument-Diode Laser ModelDLH-062017-06-29

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