FDA.reportPublic FDA data

LightScalpel

Primary DI
00851842007531
Brand
LightScalpel
Company
Lightscalpel, LLC
Model
LSH-CB
Catalog number
LS9026-01
Device description
Focused, Compact Backstop Handpiece
Published
2019-03-22
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851842007531Direct MarkingGS10
00851842007524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851842007531008518420075318518420075310851842007531
00851842007524008518420075248518420075240851842007524

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
00851842007036LightScalpelLSH-FST.25LS9009-012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
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
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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