510(k) K254038
K254038 is an FDA 510(k) premarket notification submitted by Click Therapeutics, Inc. for the device "Motivista (CT-155)". The FDA issued a decision of Substantially Equivalent on Jul 30, 2026. The device falls under product code SAP (Computerized Behavioral Therapy Device For Depressive Disorders.), a Class II device regulated under 21 CFR 882.5801. Click Therapeutics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2026
- Date Received
- Dec 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Behavioral Therapy Device For Depressive Disorders.
- Device Class
- Class II
- Regulation Number
- 882.5801
- Review Panel
- NE
- Submission Type
The device is intended to provide computerized behavioral therapy to treat depressive disorders.