K160075 is an FDA 510(k) clearance for the Accent XL. This device is classified as a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMI).
Submitted by Alma Lasers, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on August 17, 2016, 216 days after receiving the submission on January 14, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K160075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2016 |
| Decision Date | August 17, 2016 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMI - Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |