510(k) K232564
K232564 is an FDA 510(k) premarket notification submitted by Laon Medi, Inc. for the device "Align Studio". The FDA issued a decision of Substantially Equivalent on March 12, 2024. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. Laon Medi, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2024
- Date Received
- August 24, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Software
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.