ONE — Powered Light Based Non-Laser Surgical Instrument Class II
Classification Details
- Product Code
- ONE
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250224 | ismart developments | handLITE (TN19S) | April 18, 2025 |
| K171055 | philips electronics nederland | Philips BlueControl | July 6, 2017 |
| K103415 | pharos life corporation | TANDA MAX | January 3, 2011 |
| K100628 | daavlin distributing | PLASMALUXLS | November 24, 2010 |
| K091467 | silver bay | BABY QUASAR | September 17, 2010 |
| K091125 | verilux | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | September 3, 2010 |
| K092800 | led intellectual properties | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | February 4, 2010 |