LightForce Orthodontic System (LFO System)
FDA 510(k) clearance K200148 · decided 2020-02-21
Clearance details
- K-number
- K200148
- Device name
- LightForce Orthodontic System (LFO System)
- Applicant
- Lightforce Orthodontics
- Decision
- Substantially Equivalent
- Date received
- 2020-01-22
- Decision date
- 2020-02-21
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- NJM
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Cambridge, MA, US
- Third-party review
- Yes
- Expedited review
- No
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|---|---|---|
| LightForce Orthodontic System (K232827) | Lightforce Orthodontics | 2023-09-14 |
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| LightForce Orthodontic System (K222764) | Lightforce Orthodontics | 2022-09-14 |
| Vatech Clismile (K220689) | Rayence Co., Ltd. | 2022-05-06 |
| VENUS Bracket, ROSE Bracket (K201410) | Gni Co., Ltd. | 2021-03-12 |
| Luce Ceramic Bracket (K201038) | Luce Castle Co., Ltd. | 2020-10-09 |
| ROSA Bracket (K182672) | Gni Co., Ltd. | 2019-11-15 |
| Clear21 (K192202) | World Class Technology Corporation | 2019-11-12 |
| Mei Ceramic Bracket (K190608) | Orthosun Co., Ltd. | 2019-11-04 |
Recalls involving this device
No recalls on record reference this clearance.