FDA.reportPublic FDA data

Optilite

Primary DI
00855430006807
Brand
Optilite
Company
Convergent Laser Technologies
Model
OPT1080F
Device description
800 micron single-use fiber assembly with flat tip
Published
2023-06-07
Public version status
New
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
K211517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211517000Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and AccessoriesConvergent Laser Technologies2021-11-09GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855430006807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855430006807008554300068078554300068070855430006807

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA 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; a fibreoptic cable may be included with the device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark, cool, dry 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
00855430006814OptiliteOPT1010F2023-06-07
00855430006821OptiliteOPT1150FT2023-06-07
00855430006838OptiliteOPT1020FT2023-06-07
00855430006845OptiliteOPT1040FT2023-06-07
00855430006852OptiliteOPT1060FT2023-06-07

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