Submission Details
| 510(k) Number | K082087 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 23, 2008 |
| Decision Date | September 11, 2008 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
EYEFEEL OPHTHALMIC WARMER
Sep 2008
Decision
50d
Days
Class 1
Risk
About This 510(k) Submission
K082087 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 11, 2008, 50 days after receiving the submission on July 23, 2008. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.
Device Classification
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5710 |
Manufacturer
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