The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Alma Laser Nir Module.
| Device ID | K080318 |
| 510k Number | K080318 |
| Device Name: | ALMA LASER NIR MODULE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ALMA LASERS LTD. HALAMISH ST. POB 3021 INDUSTRIAL PARK Caesarea, IL 38900 |
| Contact | Tatiana Epstein |
| Correspondent | Tatiana Epstein ALMA LASERS LTD. HALAMISH ST. POB 3021 INDUSTRIAL PARK Caesarea, IL 38900 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-03-07 |
| Summary: | summary |