handLITE (TN19S)
510(k) K250224
handLITE (TN19S) is a Class II device made by iSMART Developments, Ltd., cleared under FDA 510(k) K250224 on 18 Apr 2025, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250224 | Date18 Apr 2025 | StatusActive |
Official records
- FDA 510(k) database K250224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONE
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ONE (Powered Light Based Non-Laser Surgical Instrument).