K233872 is an FDA 510(k) clearance for the Daylight. This device is classified as a Computerized Behavioral Therapy Device For Anxiety Disorders (Class II - Special Controls, product code SCP).
Submitted by Big Health, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 30, 2024, 267 days after receiving the submission on December 7, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5801. Computerized Behavioral Therapy Device For Psychiatric Disorders.
| 510(k) Number | K233872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2023 |
| Decision Date | August 30, 2024 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | SCP - Computerized Behavioral Therapy Device For Anxiety Disorders |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5801 |
| Definition | Computerized Behavioral Therapy Device For Psychiatric Disorders |