The following data is part of a premarket notification filed by Squalus Med Ltd. with the FDA for Manta Laser.
| Device ID | K222701 |
| 510k Number | K222701 |
| Device Name: | MANTA Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SQUALUS MED Ltd. 7 HaEshel Street Caesarea, IL 3088900 |
| Contact | Gil Shapira |
| Correspondent | Gil Shapira SQUALUS MED Ltd. 7 HaEshel Street Caesarea, IL 3088900 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-07 |
| Decision Date | 2022-11-18 |