Manufacturer
Surgical Laser IncorporatedSLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K151855
- Device name
- SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
- Company
- Surgical Laser Incorporated
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-07-08
- Decision date
- 2016-04-15
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope. The intended use and clinical applications are described in the User Manual of the corresponding Laser.
Intended Use
The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope. The intended use and clinical applications are described in the User Manual of the corresponding Laser.
Device Description
SLI Laser Probes are medical optical fibers to transfer the radiation emitted by a medical laser to its target at or in the patient. The laser beam conducted to pathological tissue destroys it thermally. The probes do not change the physical properties of the laser beam emitted by the laser device. The devices are sold sterile (EO) and are ready to use.
Summary parsed at:2026-06-01 06:05:05 UTC