FDA product code · General, Plastic Surgery · Class 2
ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
ONF is FDA's product code for "Powered Light Based Non-Laser Surgical Instrument With Thermal Effect": a Class 2 device classified under 21 CFR 878.4810, reviewed by the General, Plastic Surgery panel.
510(k) review time for ONF
Across 31 510(k) clearances under ONF decided from 2018-01-01 to 2026-10-06, the median was 94 days from FDA receipt to decision. Half took between 80 and 161 days, and 80% were decided within 183 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 80 |
| Median | 94 |
| 75th percentile | 161 |
| 80th percentile | 183 |
| 90th percentile | 237 |
| Slowest | 796 |
| Year | Median days | n |
|---|---|---|
| 2023 | 86 | 5 |
| 2024 | 168 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ONF in the public FDA record
| 510(k) clearances, all years | 74 |
|---|---|
| Establishment listings | 158 |
Counts of records, not of devices or events. Adverse event reports for ONF are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ONF
6 FDA recognized consensus standards cite ONF, among them ANSI IES RP-27.2-00/R17; IEC 60601-2-57 Edition 1.0 2011-01; IEC 62471 First edition 2006-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-102 ANSI IES RP-27.2-00/R17 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques
- 12-242 IEC 60601-2-57 Edition 1.0 2011-01 — Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- 12-249 IEC 62471 First edition 2006-07 — Photobiological safety of lamps and lamp systems
- 12-297 ANSI IES RP-27.1-2015 — Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
- 12-321 ANSI IES RP-27.3-17 — Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
- 12-355 IEC 60601-2-57 Edition 2.0 2023-07 — Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring cosmetic and aesthetic use
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.