Submission Details
| 510(k) Number | K043586 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2004 |
| Decision Date | May 06, 2005 |
| Days to Decision | 129 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Abbreviated
LASER SYS*STIM 540, MODEL ME 540
May 2005
Decision
129d
Days
Class 2
Risk
About This 510(k) Submission
K043586 is an FDA 510(k) clearance for the LASER SYS*STIM 540, MODEL ME 540, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on May 6, 2005, 129 days after receiving the submission on December 28, 2004. 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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