Submission Details
| 510(k) Number | K061080 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 2006 |
| Decision Date | June 14, 2006 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
IR PRO 250
Jun 2006
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K061080 is an FDA 510(k) clearance for the IR PRO 250, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Lhasa Oms, Inc. (Weymouth, US). The FDA issued a Cleared decision on June 14, 2006, 57 days after receiving the submission on April 18, 2006. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.
Device Classification
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5500 |
Manufacturer
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