The following data is part of a premarket notification filed by Lightforce Orthodontics with the FDA for Lightforce Orthodontic System.
| Device ID | K222764 |
| 510k Number | K222764 |
| Device Name: | LightForce Orthodontic System |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | LightForce Orthodontics 44 Third Ave Burlington, MA 01803 |
| Contact | Kelsey Fafara |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-09-13 |
| Decision Date | 2022-09-14 |