MAXReach Laser Probe— 510(k) K191846
Substantially EquivalentVortex Surgical, Inc.
FDA 510(k) clearance K191846 for MAXReach Laser Probe, Substantially Equivalent on 2019-12-23. Applicant: Vortex Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Vortex Surgical, Inc.
- 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
- Chesterfield, MO, US
Recent devices under product code HQB
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- K122997 — 23GA CURVED ILLUMINATING LASER PROBE
- K122905 — PEREGRINE 23GA CURVED LASER PROBE
Adverse 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.