Clearance Summary
Illusion Aligner Pro: Illusion Aligner FLX received FDA 510(k) clearance under submission number K233356, sponsored by Laxmi Dental Export Pvt., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-08-08.
- Submission: K233356
- Applicant / Sponsor: Laxmi Dental Export Pvt., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2024-08-08
Classification & Regulation
This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.