FDA.report

ScopeSafe Laser Fiber with SoftTip

Primary DI
B145116070
Brand
ScopeSafe Laser Fiber with SoftTip
Company
OPTICAL INTEGRITY INC
Model
11607
Catalog number
SU-200-TRUE-ST
Device description
200 micrometer ScopeSafe™ Laser Fiber with SoftTip™
Published
2018-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B145116111PackageHIBCC5In Commercial Distribution
B145116070PrimaryHIBCC0

GMDN Terms

TermDefinition
General/multiple surgical laser system beam guide, reusableA 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 reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Outer Diameter375Micrometer

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius37 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(850) 233-5512customercare@opticalintegrity.
(850) 233-5512customercare@opticalintegrity.com

Regulatory Flags

DUNS number
024050887
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810077631461200 micron soft tip laser fiber11531115312025-08-29
00081007763051200 micron Soft Tip laser fiber11531115312025-05-20
00810077631454357 micron laser fiber11949119492025-04-30
00810077631447Stripper Scribe Tool113822025-04-11
00810077631430200 micron Excalibur DC laser fiber11952119522025-02-28
00810077631393300 micron laser fiber (KTP) with ScopeGuardian sheath119402024-09-24
00810077631362300 micron laser fiber (KTP)119112024-09-06
00810077631355300 micron laser fiber (KTP)11637116372024-08-09
00810077630969SmartScopeSU-200-RT119202024-03-22
00810077630976SmartScopeSU-365-RT119222024-03-22
00810077630983SmartScopeSU-550-RT119232024-03-22
00810077630990SmartScopeSU-1000-RT119242024-03-22
00810077631348SmartScopeSU-200-TRUE-RT119192024-03-22
00810077635711200 TRUE ForTec Thulium TFL Laser FiberFT-0200S-RT-00C-BLK-1118542021-07-06
00810077635728272 ForTec Thulium TFL Laser FiberFT-0272S-RT-00C-BLK-1118592021-07-06
00810077635735365 ForTec Thulium TFL Laser FiberFT-0365S-RT-00C-BLK-1118642021-07-06
00810077635742550 ForTec Thulium TFL Laser FiberFT-0550S-RT-00C-BLK-1118692021-07-06
008100776357591000 ForTec Thulium TFL Laser FiberFT-1000S-RT-00C-BLK-1118742021-07-06
00810077635766200 TRUE Excalibur TorTec Thulium TFL Laser FiberFT-0200S-FT-STC-BLK-1118792021-07-06
00810077635773272 Excalibur ForTec Thulium TFL Laser FiberFT-0272S-FT-STC-BLK-1118842021-06-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08052286590500LASER THERMAL THERAPY KIT S EELESTA SPAGEX2026-03-24
08052286590517LASER THERMAL THERAPY KIT L EELESTA SPAGEX2026-03-24
06975617991024DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
02816901023318NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
01816901024156NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
00860015460615NextGen Aesthetics CO2T AESTHETICS LLCGEX2026-03-12
00860015460639NextGen Aesthetics LHRT AESTHETICS LLCGEX2026-03-12
08034108512877TORODEKA M.E.L.A. SRLGEX2026-03-11
00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCGEX2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02