iSMART Developments, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250224 | handLITE (TN19S) | April 18, 2025 |
| K242382 | décoLITE LED Device | November 8, 2024 |
| K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | July 27, 2023 |