Manufacturer
Patient Pocket, LLCLaser Dock
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K152636
- Device name
- Laser Dock
- Company
- Patient Pocket, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-09-15
- Decision date
- 2015-12-17
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The LaserDock is designed for use with Ho:YAG, Nd:YAG, CO2 and KTP laser systems when laser fibers are deployed.
Intended Use
The LaserDock is designed for use with Ho:YAG, Nd:YAG, CO2 and KTP laser systems when laser fibers are deployed.
Summary parsed at:2026-06-01 06:11:42 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
1 submission cite K152636 as a predicate