handLITE (TN19S)
FDA 510(k) clearance K250224 · decided 2025-04-18
Clearance details
- K-number
- K250224
- Device name
- handLITE (TN19S)
- Applicant
- iSMART Developments, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-27
- Decision date
- 2025-04-18
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- ONE
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Birmingham, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Philips BlueControl (K171055) | Philips Electronics Nederland B.V. | 2017-07-06 |
| TANDA MAX (K103415) | Pharos Life Corporation | 2011-01-03 |
| PLASMALUXLS (K100628) | Daavlin Distributing Co. | 2010-11-24 |
| BABY QUASAR (K091467) | Silver Bay, LLC | 2010-09-17 |
| CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 (K091125) | Verilux | 2010-09-03 |
| ANTI-WRINKLE (AGING) LIGHT, MODEL AAL (K092800) | Led Intellectual Properties, LLC | 2010-02-04 |
Recalls involving this device
No recalls on record reference this clearance.