Submission Details
| 510(k) Number | K112016 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 2011 |
| Decision Date | February 10, 2012 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
L-SER KO LAMP
Feb 2012
Decision
211d
Days
Class 2
Risk
About This 510(k) Submission
K112016 is an FDA 510(k) clearance for the L-SER KO LAMP, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Ya-Man, Ltd. (Richmond, US). The FDA issued a Cleared decision on February 10, 2012, 211 days after receiving the submission on July 14, 2011. 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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