The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Accent Xl.
| Device ID | K160075 |
| 510k Number | K160075 |
| Device Name: | Accent XL |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | Alma Lasers Inc. 485 Half Day Rd. Ste 100 Buffalo Grove, IL 60089 |
| Contact | Avi Farbstein |
| Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | IMI |
| Subsequent Product Code | GEI |
| Subsequent Product Code | ISA |
| Subsequent Product Code | NUV |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-14 |
| Decision Date | 2016-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121690 | K160075 | 000 |
| 07290110122324 | K160075 | 000 |
| 07290110122331 | K160075 | 000 |
| 07290110122348 | K160075 | 000 |
| 17290110121768 | K160075 | 000 |
| 17290110121775 | K160075 | 000 |
| 17290110121355 | K160075 | 000 |
| 17290110121607 | K160075 | 000 |
| 17290110121614 | K160075 | 000 |
| 17290110121683 | K160075 | 000 |
| 07290110122317 | K160075 | 000 |