Cleared Traditional

MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

K000728 · Medtronic Xomed · General & Plastic Surgery
Mar 2000
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K000728 is an FDA 510(k) clearance for the MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on March 21, 2000, 15 days after receiving the submission on March 6, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K000728 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2000
Decision Date March 21, 2000
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FST — Light, Surgical, Fiberoptic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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