K141861 is an FDA 510(k) clearance for the HILTHERA 4.0. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Jeisys Medical, Inc. (Fullerton, US). The FDA issued a Cleared decision on January 7, 2015, 181 days after receiving the submission on July 10, 2014.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K141861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2014 |
| Decision Date | January 07, 2015 |
| Days to Decision | 181 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 |