Vitreq disposable laser probes, light fibers and Chandelier— 510(k) K182646
Substantially EquivalentVitreQ BV
FDA 510(k) clearance K182646 for Vitreq disposable laser probes, light fibers and Chandelier, Substantially Equivalent on 2019-05-01. Applicant: VitreQ BV. Device class: 2.
Clearance details
- Applicant
- VitreQ BV
- Product code
- Code HQB
- Device class
- Class 2
- Regulation
- 21 CFR 886.4690
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vierpolders, NL
Recent devices under product code HQB
view all- K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- K191846 — MAXReach Laser Probe
- K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE
- K122997 — 23GA CURVED ILLUMINATING LASER PROBE
- K122905 — PEREGRINE 23GA CURVED LASER PROBE
More clearances from VitreQ BV
view allAdverse events under product code HQB
product code HQB- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.