FDA.reportPublic FDA data

E1 Handpiece, LT

Primary DI
07290016784107
Brand
E1 Handpiece, LT
Company
LIGHT INSTRUMENTS LTD
Model
AS78251
Catalog number
AS78251
Device description
Handpiece for the LightTouch system.
Published
2017-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
07290016784107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016784107072900167841077290016784107

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+972-732563202Office@light-inst.com

Regulatory Flags#

DUNS number
514489314
Device count
1
Sterilization required before use
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
07290016784060TIP for LITETOUCHENDO LI-FG4001(X)2022-12-01
07290016784015LiteTouchLI-FG0012ALI-FG0012A2017-01-01
07290016784022LiteTouch ApplicatorLI-FG0015ALI-FG0015A2017-01-01
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
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