Cleared Traditional

Vitra 810

K201502 · Quantel Medical · Ophthalmic
Aug 2020
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K201502 is an FDA 510(k) clearance for the Vitra 810, 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 August 6, 2020, 62 days after receiving the submission on June 5, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K201502 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2020
Decision Date August 06, 2020
Days to Decision 62 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