K122125 is an FDA 510(k) clearance for the ASA LASER SH1. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on January 25, 2013, 191 days after receiving the submission on July 18, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K122125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2012 |
| Decision Date | January 25, 2013 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |