FDA.reportPublic FDA data

TIP for LITETOUCH

Primary DI
07290016784060
Brand
TIP for LITETOUCH
Company
LIGHT INSTRUMENTS LTD
Model
ENDO
Catalog number
LI-FG4001(X)
Device description
Package of 5 single-use tips for the LITETOUCH system
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K061966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061966000LITETOUCH DENTAL LASER SYSTEMLight Instrument, Ltd.2006-09-27GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016784060PrimaryGS10
37290016784061Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016784060072900167840607290016784060
3729001678406137290016784061

GMDN Terms#

Term, Definition table
TermDefinition
Dental solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514489314
Device count
5
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016784039D-STORM1LI-FGD001(X)2023-01-08
07290016784046D-STORM1LI-FGD002(X)2023-01-08
07290016784008TIP for LITETOUCHD-1.0 mm L-10 mmAS7078X 2022-12-01
07290016784053TIP for LITETOUCHD-0.8 mm L-8 mmAS7077X 2022-12-01
07290016784015LiteTouchLI-FG0012ALI-FG0012A2017-01-01
07290016784022LiteTouch ApplicatorLI-FG0015ALI-FG0015A2017-01-01
07290016784107E1 Handpiece, LTAS78251AS782512017-01-01
07290016784114Straight Handpiece, LTAS72301AS723012017-01-01
07290016784206TIP for LITETOUCHSPECIALTY TIPS SIDED ALI-AS300402017-01-01
07290016784213TIP for LITETOUCH SPECIALTLY TIPS SIDE BLI-AS300502017-01-01
07290016784305TIP for LITETOUCHD-0.2mm L-17mm AS756512017-01-01
07290016784312TIP for LITETOUCHD-0.4mm L-17mm AS707522017-01-01
07290016784329TIP for LITETOUCHD-0.6mm L-17mm AS707222017-01-01
07290016784336TIP for LITETOUCHD-0.8mm L-14mm AS707422017-01-01
07290016784343TIP for LITETOUCHD-0.8mm L-17mmAS706922017-01-01
07290016784350TIP for LITETOUCHD-1.0mm L-14mm AS707322017-01-01
07290016784367TIP for LITETOUCHD-1.0mm L-17mmAS706822017-01-01
07290016784374TIP for LITETOUCHD-1.3mm L-14mm AS706622017-01-01
07290016784381TIP for LITETOUCHD-1.3mm L-17mmAS706522017-01-01
07290016784398TIP for LITETOUCHD-1.3mm L-19mm AS707122017-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800291820200DermaVCynosure Lutronic Technology CorporationGEX2026-06-23
08800291820040CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820057CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820187CLARITY IICynosure Lutronic Technology CorporationGEX2026-06-22
08800291820460HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820477HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820484HOLLYWOOD SPECTRACynosure Lutronic Technology CorporationGEX2026-06-22
08800291820859PICOPLUSCynosure Lutronic Technology CorporationGEX2026-06-22
06973511890177SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-06-10
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
00647529004722Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemBiolase, Inc.GEX2025-01-31
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00850064466027FREDDOFABINJECT LLCGEX2024-10-28
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
00860007603761Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16
00860007603747Sentient ManufacturingSentient Manufacturing, LLCGEX2022-09-16