FDA.reportPublic FDA data

Optilite

Primary DI
00855430006180
Brand
Optilite
Company
Convergent Laser Technologies
Model
EZ1060F
Device description
600 micron thin jacket 4m fiber assembly with flat tip
Published
2017-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
K951760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951760000OPTILITE VIII LASER SURGERY ACCESSORIESXintec Corporation1995-11-29GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855430006180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855430006180008554300061808554300061800855430006180

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-use, sterileA sterile, surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Regulatory Flags#

DUNS number
177735305
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855430006890OptiliteCGH1020B2024-01-09
00855430006500OptiliteSGH1010F2023-06-07
00855430006517OptiliteURO1020F2023-06-07
00855430006524OptiliteURO1040F2023-06-07
00855430006531OptiliteURO1020FL2023-06-07
00855430006548OptiliteURO1040FL2023-06-07
00855430006555OptiliteEZ1010F2023-06-07
00855430006722OptiliteURO1020R2023-06-07
00855430006739OptiliteURO1040R2023-06-07
00855430006746OptiliteURO1060R2023-06-07
00855430006753OptiliteOPT602023-06-07
00855430006760OptiliteOPT1150F2023-06-07
00855430006777OptiliteOPT1020F2023-06-07
00855430006784OptiliteOPT1040F2023-06-07
00855430006791OptiliteOPT1060F2023-06-07
00855430006807OptiliteOPT1080F2023-06-07
00855430006814OptiliteOPT1010F2023-06-07
00855430006821OptiliteOPT1150FT2023-06-07
00855430006838OptiliteOPT1020FT2023-06-07
00855430006845OptiliteOPT1040FT2023-06-07

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
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
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
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14