Powered Light Based Non-Laser Surgical Instrument
The Powered Light Based Non-Laser Surgical Instrument (product code ONE) is a Class 2 surgical device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is a non-laser light-based device typically indicated for general surgical purposes across specialties including general and plastic surgery, dermatology, podiatry, ENT, gynecology, neurosurgery, orthopedics, and dental/oral surgery. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- ONE
- Device Class
- FDA class 2
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250224 | handLITE (TN19S) | Apr 18, 2025 | Substantially Equivalent | iSMART Developments, Ltd. |
| K171055 | Philips BlueControl | Jul 06, 2017 | Substantially Equivalent | Philips Electronics Nederland B.V. |
| K103415 | TANDA MAX | Jan 03, 2011 | Substantially Equivalent | Pharos Life Corporation |
| K100628 | PLASMALUXLS | Nov 24, 2010 | Substantially Equivalent | Daavlin Distributing Co. |
| K091467 | BABY QUASAR | Sep 17, 2010 | Substantially Equivalent | Silver Bay, LLC |
| K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Sep 03, 2010 | Substantially Equivalent | Verilux |
| K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Feb 04, 2010 | Substantially Equivalent | Led Intellectual Properties, LLC |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.