Cleared Traditional

FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA

K043236 · Quantel Medical · Ophthalmic

Feb 2005

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K043236 is an FDA 510(k) clearance for the FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (Hot Springs, US). The FDA issued a Cleared decision on February 7, 2005, 77 days after receiving the submission on November 22, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K043236 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2004
Decision Date	February 07, 2005
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF