The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Modified Alma Lasers Harmony 1064nm (nd:yag) Modules.
| Device ID | K113810 |
| 510k Number | K113810 |
| Device Name: | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 Buffalo Grove, IL 60089 |
| Contact | Tatiana Epstein |
| Correspondent | Tatiana Epstein ALMA LASERS INC. 485 HALF DAY RD. SUITW NO. 100 Buffalo Grove, IL 60089 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-03-08 |
| Summary: | summary |