510(k) K250224
- Device
- handLITE (TN19S)
- Applicant
- iSMART Developments, Ltd.
- 510(k) number
- K250224
- Product code
- ONE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-18
- Date received
- 2025-01-27
- Regulation
- 878.4810
- Classification name
- Powered Light Based Non-Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Susan D'Arcy
- Address
- 129 Green Ln.s, Wylde Green Birmingham GB B73 5LT B73 5LT
FDA Registration Numbers#
- 3006716777
- 3008442971
- 3013481783
- 1526255
Source Documents#
Other 510(k) Records For Product Code ONE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171055 | Philips BlueControl | Philips Electronics Nederland B.V. | 2017-07-06 |
| K103415 | TANDA MAX | Pharos Life Corporation | 2011-01-03 |
| K100628 | PLASMALUXLS | Daavlin Distributing Co. | 2010-11-24 |
| K091467 | BABY QUASAR | Silver Bay, LLC | 2010-09-17 |
| K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Verilux | 2010-09-03 |
| K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Led Intellectual Properties, LLC | 2010-02-04 |