Manufacturer
Cook IncorporatedCook Holmium Laser 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
- K163197
- Device name
- Cook Holmium Laser Fiber
- Company
- Cook Incorporated
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-11-15
- Decision date
- 2017-05-24
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cuttingAcne treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Intended for stone fragmentation, incision, excision, ablation, coagulation (hemostasis) when attached to the H-30 Holmium Laser System or Odyssey Holmium Laser System for the indications for which the lasers have been cleared.
Intended Use
Intended for stone fragmentation, incision, excision, ablation, coagulation (hemostasis) when attached to the H-30 Holmium Laser System or Odyssey Holmium Laser System for the indications for which the lasers have been cleared.
Device Description
The Cook Holmium Laser Fibers are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in four different sizes, and will be sold in boxes of three.
Summary parsed at:2026-06-01 05:59:17 UTC