FDA.reportPublic FDA data

LightScalpel

Primary DI
00851842007357
Brand
LightScalpel
Company
Lightscalpel, LLC
Model
LS9005-07
Catalog number
LS9005-07 Box
Device description
Tip, 0.25mm Spot, Thinwall, Sterile, 5 Pack
Published
2018-01-17
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

Contact Domains#

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
K081612000
K121471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081612000AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERSAesculight, LLC2008-06-25GEX
K121471000LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERSLightscalpel, LLC2012-07-10GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851842007357PrimaryGS10
00851842007340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851842007357008518420073578518420073570851842007357
00851842007340008518420073408518420073400851842007340

GMDN Terms#

Term, Definition table
TermDefinition
Laser adaptorA connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length20Millimeter
Lumen/Inner Diameter0.25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-697-7548info@lightscalpel.com

Regulatory Flags#

DUNS number
033516010
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851842007623LightScalpelLS-4020LS9032-01, LS9038-012023-06-26
00851842007197LightScalpelLS-2010LS9018-01, LS9018-04, LS9030-02, LS9030-05, LS90372016-09-24
00851842007180LightScalpelLS-1005LS9011-02, LS9011-03, LS9011-04, LS9030-01, LS90302016-09-24
00851842007685LightScalpelLSH-XLSLS9035-012024-04-25
00851842007661LightScalpelLS9034-01LS9034-012023-06-16
00851842007562LightScalpelLS9028-01LS9028-012020-08-26
00851842007579LightScalpelLS9028-02LS9028-022020-08-26
00851842007654LightScalpelLSH-LSLBLS9029-022022-10-21
00851842007630LightScalpelLSH-SCBLS9033-012022-09-13
00851842007647LightScalpelLSH-SCBLS9033-012022-09-13
00851842007609LightScalpelLSH-HCBLS9031-012020-12-22
00851842007616LightScalpelLSH-HCBLS9031-012020-12-22
00851842007586LightScalpelLSH-LSTLLS9029-012020-08-26
00851842007593LightScalpelLSH-LSTLLS9029-012020-08-26
00851842007548LightScalpelLSH-ACBLS9027-012019-09-24
00851842007555LightScalpelLSH-ACBLS9027-012019-09-24
00851842007289LightScalpelLS9005-05LS9005-05 Pouch2016-09-24
00851842007296LightScalpelLS9005-06LS9005-06 Pouch2016-09-24
00851842007524LightScalpelLSH-CBLS9026-012019-03-22
00851842007531LightScalpelLSH-CBLS9026-012019-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
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