The following data is part of a premarket notification filed by Paradigm Medical Corporation with the FDA for Multifrax Laser System.
| Device ID | K213332 |
| 510k Number | K213332 |
| Device Name: | Multifrax Laser System |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | Paradigm Medical Corporation 7371 Los Brazos San Diego, CA 92127 |
| Contact | Nikolai Tankovich |
| Correspondent | Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-06 |
| Decision Date | 2022-06-03 |