The following data is part of a premarket notification filed by Lightforce Orthodontics with the FDA for Lightforce Orthodontic System (lfo System).
| Device ID | K200148 |
| 510k Number | K200148 |
| Device Name: | LightForce Orthodontic System (LFO System) |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | LightForce Orthodontics 1035 Cambridge Street, Suite 14a Cambridge, MA 02141 |
| Contact | Amos N Benninga |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-01-22 |
| Decision Date | 2020-02-21 |