Cleared Traditional

Capsulo

K220430 · Quantel Medical · Ophthalmic
May 2022
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K220430 is an FDA 510(k) clearance for the Capsulo, 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 May 12, 2022, 86 days after receiving the submission on February 15, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K220430 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2022
Decision Date May 12, 2022
Days to Decision 86 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