Cleared Traditional

SOLUTIS

K130933 · Quantel Medical · Ophthalmic
Aug 2013
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K130933 is an FDA 510(k) clearance for the SOLUTIS, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (North Reading, US). The FDA issued a Cleared decision on August 2, 2013, 120 days after receiving the submission on April 4, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K130933 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2013
Decision Date August 02, 2013
Days to Decision 120 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