FDA Classifies a Light Therapy Device for Post-Surgical Scars as Class II

The Food and Drug Administration has officially placed a specific medical device into Class II. The device, called the Klox Biophotonic LumiHeal System, uses light energy and a photoconverter gel to reduce the appearance of fresh surgical scars. FDA took this action after Klox Technologies requested a De Novo classification, which is the process used when a new device does not match any already on the market.

Why it matters: This action is mostly administrative, but it clears a regulatory path for a specific type of scar-reduction device. By defining the exact safety tests and labeling requirements, FDA gives manufacturers a predictable route to market. It also prevents these devices from being stuck in the automatic Class III category, which would require a more expensive and time-consuming premarket approval application. The practical effect is that similar devices can now enter the market under a standardized, mid-level review process.

Who it affects

• Klox Technologies and other manufacturers of light-based devices for fresh surgical scars

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This final order was issued by the Food and Drug Administration and published in the Federal Register; readers relying on the regulatory details should consult the official document at 21 CFR 878.4880.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document