FDA.reportPublic FDA data

CoolLipoTM

Primary DI
04059497000723
Brand
CoolLipoTM
Company
LEONI Fiber Optics GmbH
Model
CL 500 S
Catalog number
M210608S
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050738000FT FIBER OPTIC DELIVERY SYSTEMSFibertech GmbH2005-06-02GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059497000730PackageGS15In Commercial Distribution
04059497000747PackageGS12In Commercial Distribution
04059497000723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059497000730040594970007304059497000730
04059497000747040594970007474059497000747
04059497000723040594970007234059497000723

GMDN Terms#

Term, Definition table
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 incise, excise, ablate, 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.

Regulatory Flags#

DUNS number
342703174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059497000037CoolLipoTMCL 320 SM210273S2016-09-29
04059497000068FiberTech®FT IR200/240ST-3/SL-F 1500K3LM220150S2016-09-29
04059497000075FiberTech®FT IR272/300ST-3/SL-F 1500K3LM220200S2016-09-29
04059497000082FiberTech®FT IR365/400ST-3/SL-F 1500K3LM220300S2016-09-29
04059497000099FiberTech®FT IR550/605ST-3/SL-F 1500K3LM220500S2016-09-29
04059497000105CoolLipoTMCL 500 RM220522N2016-09-29
04059497000112CoolLipoTMCL 320 RM220921N2016-09-29
04059497000006FiberTech®FT IR600/720HCN-3/SF-2050 003001CM102962S2016-09-29
04059497000198FiberTech®FT IR600/720HCN-3/SL-SF-1750 003711CM280202S2016-09-29
04059497000204FiberTech®FT IR600/720HCN-3/SL-SF-2050 L12011FM280311S2016-09-29
04059497000211FiberTech®FT IR600/720HCN-3/SL-SF-2050 L12011FM280317S2016-09-29
04059497000488FiberTech®FT IR600/720HCN-3/SL-SF-2050 0S2011FM280317S2017-08-08
04260438610028FiberTech®FT IR600/720HCN-3/SL-SF-2000 012011LM280300S2016-09-29
04059497000013FiberTech®FT IR200/240ST-3/SL-F 120011LM210150S2016-09-29
04059497000020FiberTech®FT IR273/300ST-3/SL-F 120011LM210200S2016-09-29
04059497000044FiberTech®FT IR365/400ST-3/SL-F 120011LM210300S2016-09-29
04059497000051FiberTech®FT IR550/605ST-3/SL-F 120011LM210500S2016-09-29
04059497000129FiberTech®FT IR210/220A-2.5/SM-ES23 000311LM270200S2016-09-29
04059497000136FiberTech®FT IR200/220PI-2.5/SMI-ES23 5K0CK1FM270202S2016-09-29
04059497000143FiberTech®FT IR210/220A-2.5/SM-EC23 000311LM270250S2016-09-29

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