FDA.reportPublic FDA data

CoolLipoTM

Primary DI
04059497000112
Brand
CoolLipoTM
Company
LEONI Fiber Optics GmbH
Model
CL 320 R
Catalog number
M220921N
Published
2016-09-29
Public version status
Update
Distribution status
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

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
04059497000358PackageGS15In Commercial Distribution
04059497000594PackageGS12In Commercial Distribution
04059497000112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059497000358040594970003584059497000358
04059497000594040594970005944059497000594
04059497000112040594970001124059497000112

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342703174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059497000037CoolLipoTMCL 320 SM210273S2016-09-29
04059497000723CoolLipoTMCL 500 SM210608S2016-09-29
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
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
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
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
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390090Twain EvoQUANTA SYSTEM SPAGEX2018-12-14