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SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber

Surgical Laser Incorporated

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Surgical Laser Incorporated
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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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

Predicate devices

2

K151855 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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