Cleared Traditional

EYEFEEL OPHTHALMIC WARMER

K021843 · Bio-Lipid, Inc. · Physical Medicine

Sep 2002

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K021843 is an FDA 510(k) clearance for the EYEFEEL OPHTHALMIC WARMER, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Bio-Lipid, Inc. (Washington, US). The FDA issued a Cleared decision on September 3, 2002, 90 days after receiving the submission on June 5, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number	K021843 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2002
Decision Date	September 03, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF