The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Alma Lasers Family Of Pixel Rf Tips.
| Device ID | K121150 |
| 510k Number | K121150 |
| Device Name: | ALMA LASERS FAMILY OF PIXEL RF TIPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 Buffalo Grove, IL 60089 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 Buffalo Grove, IL 60089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-09-21 |
| Summary: | summary |