Cleared Traditional

INTEGRE LIO

K251507 · Quantel Medical · Ophthalmic
Feb 2026
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K251507 is an FDA 510(k) clearance for the INTEGRE LIO, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (Cournon D'Auvergne-Cedex, FR). The FDA issued a Cleared decision on February 6, 2026, 266 days after receiving the submission on May 16, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K251507 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2025
Decision Date February 06, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390