The following data is part of a premarket notification filed by Endymed Medical, Ltd. with the FDA for Pure Laser.
| Device ID | K222369 |
| 510k Number | K222369 |
| Device Name: | PURE Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Endymed Medical, Ltd. 12 Leshem St. North Industrial Park, PO Box 3582 Caesarea, IL 3088900 |
| Contact | Ohad Fisher |
| Correspondent | Ohad Fisher Endymed Medical, Ltd. 12 Leshem St. North Industrial Park, PO Box 3582 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 | 2022-08-05 |
| Decision Date | 2022-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016814378 | K222369 | 000 |
| 07290016814361 | K222369 | 000 |