FDA.reportPublic FDA data

SureLase

Primary DI
00850013050215
Brand
SureLase
Company
Clinicon Corporation
Model
4060
Device description
"Clinicon ""SureLase"" 30 Watt Laser System, 3-Year Warranty"
Published
2021-05-05
Public version status
New
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
K121580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121580000SURELASE CO2 LASER SYSTEMClinicon Corp.2012-09-25GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013050215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013050215008500130502158500130502150850013050215

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode/carbon dioxide laser systemA mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one diode mediated, and the other carbon dixoide (CO2) mediated, intended for aesthetic and tissue reconstructive applications across multiple clinical specialties (e.g., dermatological, gynaecological, urological applications) using both ablative and non-ablative lasing. It includes a laser generator with controls and a monitor.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785275777
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013050154SureGuide40342021-05-06
00850013050161SureGuide41402021-05-06
00850013050178SureGuide31562021-05-06
00850013050185SureGuide41432021-05-06
00850013050000SureProbe40002021-05-05
00850013050017SureProbe40012021-05-05
00850013050024SureProbe40022021-05-05
00850013050031SureProbe40072021-05-05
00850013050048SureProbe40032021-05-05
00850013050055SureProbe40082021-05-05
00850013050062SureProbe40042021-05-05
00850013050079SureProbe41592021-05-05
00850013050086SureProbe41492021-05-05
00850013050093SureProbe40112021-05-05
00850013050116SureTouch40122021-05-05
00850013050123SureTip37282021-05-05
00850013050130SureBlade25722021-05-05
00850013050147SureBlade29862021-05-05
00850013050192SureScan35662021-05-05
00850013050208Luxar41512021-05-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16