The following data is part of a premarket notification filed by Alma Inc. with the FDA for Harmony Lite.
| Device ID | K141237 |
| 510k Number | K141237 |
| Device Name: | HARMONY LITE |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | ALMA INC. 26 REBECCA CT. Homosassa, FL 34446 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor ALMA INC. 26 REBECCA CT. Homosassa, FL 34446 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-13 |
| Decision Date | 2015-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121454 | K141237 | 000 |
| 17290110120938 | K141237 | 000 |
| 17290110120563 | K141237 | 000 |
| 17290110120556 | K141237 | 000 |