FDA.reportPublic FDA data

LightScalpel

Primary DI
00851842007623
Brand
LightScalpel
Company
Lightscalpel, LLC
Model
LS-4020
Catalog number
LS9032-01, LS9038-01
Device description
LS-4020, 40W CO2 Laser System
Published
2023-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K123037000
K132661000
K141658000
K213669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123037000LIGHTSCALPELLightscalpel, LLC2012-11-29GEX
K132661000LIGHTSCALPELLightscalpel, LLC2014-01-02GEX
K141658000LIGHT SCALPELLightscalpel, LLC2014-10-22GEX
K213669000LIGHTSCALPEL LS-4020Lightscalpel, Inc.2023-02-15GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851842007623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851842007623008518420076238518420076230851842007623

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological carbon dioxide laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, scar treatment, skin tightening, and lesion/hair/tattoo removal. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Non-Condensing
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
033516010
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00851842007036LightScalpelLSH-FST.25LS9009-012016-09-24

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
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
08059173390786Single 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