LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS— 510(k) K122829
Substantially EquivalentLensar, Inc.
FDA 510(k) clearance K122829 for LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS, Substantially Equivalent on 2012-12-03. Applicant: Lensar, Inc.. Device class: 2.
Clearance details
- Applicant
- Lensar, Inc.
- Product code
- Product code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code HQC
view allMore clearances from Lensar, Inc.
view allAdverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
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.