The following data is part of a premarket notification filed by Yolo Medical, Inc. with the FDA for Curve Laser System.
| Device ID | K170709 |
| 510k Number | K170709 |
| Device Name: | CURVE Laser System |
| Classification | Fat Reducing Low Level Laser |
| Applicant | YOLO Medical, Inc. 1959 152nd Street, Suite 245 Surrey, CA V4a 9e3 |
| Contact | Robert 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 | 2017-03-08 |
| Decision Date | 2017-06-06 |
| Summary: | summary |