The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Harmony Xl Multi-application Platform.
| Device ID | K181298 |
| 510k Number | K181298 |
| Device Name: | Harmony XL Multi-Application Platform |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | Alma Lasers Inc. 485 Half Day Rd, Suite #100 Buffalo Grove, IL 60089 |
| Contact | Rekha Anand |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-06-13 |