INTEGRE LIO— 510(k) K251507
Substantially EquivalentQuantel Medical
FDA 510(k) clearance K251507 for INTEGRE LIO, Substantially Equivalent on 2026-02-06. Applicant: Quantel Medical. Device class: 2.
Summary
Quantel Medical's INTEGRE LIO is filed under product code HQF, ophthalmic laser. The record doesn't describe the laser beyond its name and that code name.
Class II, 21 CFR 886.4390. Ophthalmic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Quantel Medical filed from Cournon D'Auvergne-Cedex, France. FDA found it substantially equivalent 266 calendar days after receipt (May 16, 2025 to February 6, 2026).
Clearance details
- Applicant
- Quantel Medical
- Product code
- Product code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cournon D'Auvergne-Cedex, FR
Recent devices under product code HQF
view allMore clearances from Quantel Medical
view allAdverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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.