LaserDock, HolmiumDock, CO2Dock, OmniDock, KTPDock
510(k) K170215
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170215 | Date19 Apr 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LaserDock, HolmiumDock, CO2Dock, OmniDock, and KTPDock are sterile holster accessories designed for surgical laser systems and fiber optic laser energy delivery devices. These devices provide a secure, sterile housing for laser fibers when not in use during procedures, ensuring contamination prevention and ease of handling. Classified under the Powered Laser Surgical Instrument category (GEX), they are intended for use across multiple surgical specialties requiring laser energy.
These devices are supplied sterile and intended for single-use, adhering to Class II regulatory standards with special controls. They are compatible with various laser wavelengths, including Holmium, CO2, Omni, and KTP lasers, and are designed for secure attachment to laser fibers during surgical procedures. Storage requires adherence to sterile packaging guidelines, and their use is authorized under FDA 510(k) clearance (K170215) for powered laser surgical instruments.
Other devices from Patient Pocket, LLC
Questions
AI-generated answers, 1 Oct 2026
What are the LaserDock holsters designed for?
The LaserDock, HolmiumDock, CO₂Dock, OmniDock, and KTPDock are sterile holsters specifically engineered to securely house laser fibers when not in use during surgical procedures. They prevent contamination and ensure easy, sterile access to the fiber, making them ideal for procedures requiring Holmium, CO₂, Omni, or KTP laser energy across multiple specialties.
Are these holsters reusable or single-use?
These holsters are intended for single-use only. Their sterile packaging and design align with Class II regulatory standards, ensuring safety and compliance for one-time surgical use. Reuse is not recommended to maintain sterility and prevent cross-contamination.
How should I store the LaserDock holsters before use?
Storage must follow sterile packaging guidelines to preserve integrity. Keep the holsters in their original, unopened packaging until immediately before use. Avoid exposure to moisture, heat, or direct sunlight, as these can compromise sterility and material integrity.
Which laser wavelengths are compatible with these holsters?
The LaserDock series is designed for compatibility with multiple laser wavelengths, including Holmium, CO₂, Omni, and KTP lasers. Each variant (HolmiumDock, CO₂Dock, OmniDock, KTPDock) is tailored to securely attach to fibers used with those specific wavelengths, ensuring proper handling and sterility.
What regulatory clearance does the LaserDock holster have?
The LaserDock holsters are authorized under FDA 510(k) clearance (K170215) for powered laser surgical instruments. This clearance confirms their substantial equivalence to a predicate device and compliance with Class II regulatory standards, including special controls for sterile, single-use accessories.