The following data is part of a premarket notification filed by Yolo Medical, Inc. with the FDA for Lipofina Laser System.
| Device ID | K143741 |
| 510k Number | K143741 |
| Device Name: | Lipofina Laser System |
| Classification | Fat Reducing Low Level Laser |
| Applicant | YOLO MEDICAL, INC. 1959 152nd STREET Suite 245 Carpenteria, CA Bc V4a 9e3 |
| Contact | Robert J Krznaric |
| Correspondent | Paul Kramsky ROCKIN' REGULATORY, INC. 21831 Tumbleweed Circle Lake Forest, CA 92630 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-31 |
| Decision Date | 2015-04-24 |
| Summary: | summary |