The following data is part of a premarket notification filed by Formatk Systems Ltd. with the FDA for Magma Spark.
| Device ID | K162781 |
| 510k Number | K162781 |
| Device Name: | Magma Spark |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Formatk Systems Ltd. 3 Hayozma St. Tirat Hacarmel, IL 3903203 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. Stein – Regulatory Affairs Consulting Ltd. 20 Hata’as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2016-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016681031 | K162781 | 000 |
| 07290016681444 | K162781 | 000 |
| 07290016681437 | K162781 | 000 |
| 07290016681079 | K162781 | 000 |