The following data is part of a premarket notification filed by Formatk Systems Ltd. with the FDA for Magma System.
| Device ID | K153566 |
| 510k Number | K153566 |
| Device Name: | Magma System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FORMATK SYSTEMS LTD. 3 HAYOZMA ST. Tirat Hacarmel, IL 3903203 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A.STEIN - REGUALTORY 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016681345 | K153566 | 000 |
| 07290016681024 | K153566 | 000 |
| 07290016681208 | K153566 | 000 |
| 07290016681215 | K153566 | 000 |
| 07290016681222 | K153566 | 000 |
| 07290016681239 | K153566 | 000 |
| 07290016681246 | K153566 | 000 |
| 07290016681253 | K153566 | 000 |
| 07290016681260 | K153566 | 000 |
| 07290016681284 | K153566 | 000 |
| 07290016681291 | K153566 | 000 |
| 07290016681307 | K153566 | 000 |
| 07290016681321 | K153566 | 000 |
| 07290016681338 | K153566 | 000 |
| 07290016681086 | K153566 | 000 |