FDA product code ONE: Powered Light Based Non-Laser Surgical Instrument
ONE is the FDA product code for powered light based non-laser surgical instrument. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under ONE, 1 in the last five years, from 7 different applicants. The average 510(k) review took 230 days (median 146); 81 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Light Based Non-Laser Surgical Instrument |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ONE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
| 2025 | 1 | 81 |
Compare with all 510(k) review times · Search every ONE clearance
Top ONE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| iSMART Developments, Ltd. | 1 | 2025-04-18 |
| Philips Electronics Nederland B.V. | 1 | 2017-07-06 |
| Pharos Life Corporation | 1 | 2011-01-03 |
| Daavlin Distributing Co. | 1 | 2010-11-24 |
| Silver Bay, LLC | 1 | 2010-09-17 |
2 more applicants have ONE clearances. See the full list in Caduvo.
Most recent ONE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250224 | iSMART Developments, Ltd. | handLITE (TN19S) | 2025-04-18 | 81 |
| K171055 | Philips Electronics Nederland B.V. | Philips BlueControl | 2017-07-06 | 87 |
| K103415 | Pharos Life Corporation | TANDA MAX | 2011-01-03 | 42 |
| K100628 | Daavlin Distributing Co. | PLASMALUXLS | 2010-11-24 | 264 |
| K091467 | Silver Bay, LLC | BABY QUASAR | 2010-09-17 | 487 |
Recalls for ONE devices
openFDA lists no recalls for product code ONE.
Frequently asked questions
What is FDA product code ONE?
ONE is the FDA product code for powered light based non-laser surgical instrument. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is ONE?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONE?
Across 7 cleared submissions the average was 230 days from receipt to decision (median 146).
Which companies have the most ONE clearances?
iSMART Developments, Ltd. (1); Philips Electronics Nederland B.V. (1); Pharos Life Corporation (1); Daavlin Distributing Co. (1); Silver Bay, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONE
- Run a recall and safety report across every ONE manufacturer
- Watch product code ONE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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