The following data is part of a premarket notification filed by Formatk Systems Ltd. with the FDA for Magma Spark Pro (magma Spark Plus, Alpha).
| Device ID | K183307 |
| 510k Number | K183307 |
| Device Name: | Magma Spark Pro (Magma Spark Plus, Alpha) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Formatk Systems Ltd. 3 Hayozma St. Tirat Hacarmel, IL 3903203 |
| Contact | Amit Goren |
| Correspondent | Amit Goren 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 | 2018-11-28 |
| Decision Date | 2018-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016681390 | K183307 | 000 |
| 07290016681048 | K183307 | 000 |
| 07290016681055 | K183307 | 000 |
| 07290016681062 | K183307 | 000 |
| 07290016681123 | K183307 | 000 |
| 07290016681352 | K183307 | 000 |
| 07290016681369 | K183307 | 000 |
| 07290016681376 | K183307 | 000 |
| 07290016681383 | K183307 | 000 |
| 07290016681130 | K183307 | 000 |