Cleared Traditional

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

K000457 · Retinalabs.Com · Ophthalmic

May 2000

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K000457 is an FDA 510(k) clearance for the VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on May 9, 2000, 88 days after receiving the submission on February 11, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K000457 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2000
Decision Date	May 09, 2000
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF