The following data is part of a premarket notification filed by Formatk Systems Ltd. with the FDA for Forma System, Forma Light System.
| Device ID | K160195 |
| 510k Number | K160195 |
| Device Name: | Forma System, Forma Light System |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| 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 | ONF |
| Subsequent Product Code | GFE |
| Subsequent Product Code | ILY |
| Subsequent Product Code | PBX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016681314 | K160195 | 000 |
| 07290016681277 | K160195 | 000 |
| 07290016681109 | K160195 | 000 |
| 07290016681017 | K160195 | 000 |
| 07290016681000 | K160195 | 000 |