FDA Greenlights Easier Path for Scar-Reducing Light Therapy Devices
Published Date: 5/1/2026
Rule
Summary
The FDA is officially classifying phototherapy devices that help reduce the look of fresh surgical cuts as Class II, meaning they have special safety rules but are easier to get to patients. This change, effective May 1, 2026, makes it safer and simpler for companies to offer these devices without the toughest regulations. Patients and makers both win with better access and less red tape!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Device moved to Class II, easier market access
The FDA officially classified phototherapy devices for reducing the appearance of acute post-surgical incisions as Class II (special controls), effective May 1, 2026, with the classification applicable December 3, 2021. This puts the device in a lower regulatory class than automatic Class III and lets sponsors rely on the De Novo/510(k) pathway and enables the device to serve as a predicate for future 510(k) devices.
Manufacturers must meet special testing and labeling
To fall within Class II, manufacturers must meet special controls including non-clinical performance testing (spectrum and power verification, heat dissipation, biophotonic properties), biocompatibility and sterility testing, shelf-life demonstration for the photoconverter gel, electromagnetic/electrical/thermal safety testing, software verification/validation and hazard analysis, and specific labeling (technical specs, eye-safety warnings, and gel shelf life). These requirements are codified at 21 CFR 878.4880.
Patients may see improved access to device
FDA states that classifying these phototherapy devices into Class II will enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. The final order is effective May 1, 2026, and the device type was classified December 3, 2021.
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