Cleared Traditional

Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II

K043613 · Quantel Medical · Ophthalmic

Mar 2005

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K043613 is an FDA 510(k) clearance for the Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (Hot Springs, US). The FDA issued a Cleared decision on March 24, 2005, 84 days after receiving the submission on December 30, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K043613 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 30, 2004
Decision Date	March 24, 2005
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF