FDA.reportPublic FDA data

CoolTouch

Primary DI
00859932006150
Brand
CoolTouch
Company
NEW STAR LASERS, INC.
Model
7420-0049
Device description
Fiber Optic Catheter
Published
2016-09-20
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859932006150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859932006150008599320061508599320061500859932006150

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical 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 intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
877266163
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859932006297CoolTouch9000-04602016-09-20
00859932006303CoolTouch7435-02002016-09-20
00859932006006StoneLight 30R7300-0071NS30002016-09-20
00859932006013StoneLight 157300-0028NS18002016-09-20
00859932006037CoolTouch ReNewR7300-0055LC2252016-09-20
00859932006044CoolTouch CoolLipoR7300-0042NS1602016-09-20
00859932006051CoolTouch SaphFire7420-0023M2016-09-20
00859932006068CoolTouch SaphFire7420-00232016-09-20
00859932006075CoolTouch EZ Pass 4007420-00872016-09-20
00859932006082CoolTouch7420-00192016-09-20
00859932006099CoolTouch7420-00212016-09-20
00859932006105CoolTouch7420-00252016-09-20
00859932006112CoolTouch7420-00372016-09-20
00859932006129CoolTouch7420-00172016-09-20
00859932006136CoolTouch7420-0017G2016-09-20
00859932006143CoolTouch7420-00182016-09-20
00859932006181CoolTouch7420-00462016-09-20
00859932006211New Star Lasers7420-00132016-09-20
00859932006228New Star Lasers9500-01602016-09-20
00859932006235New Star Lasers7420-00622016-09-20

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06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16