Federal Register #2026-08497

FDA Classifies Klox Technologies Phototherapy Device for Post-Surgical Incisions as Class II Medical Device

This notice from the Food and Drug Administration (FDA) details the classification of a phototherapy device for post-surgical incision care: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Klox Technologies Inc. (OEM of the LumiHeal System) - Products/Devices: - Phototherapy device for reducing the appearance of acute post-surgical incisions - Consists of a light-emitting device and a photoconverter gel - FDA product code/part number: 878.4880 - Unique/Notable Requirements: - Device classified as Class II medical device with special controls - Biocompatibility evaluation - Sterility and shelf-life testing - Performance testing (electromagnetic compatibility, electrical and thermal safety) - Software verification and validation - Specific labeling requirements - Subject to premarket notification (510(k)) - No procurement, solicitation, or purchase of products/services is included in this notice - Additional regulatory action: DEA scheduling of four substances (not related to the device) - Key Locations: - Food and Drug Administration (federal office) - Department of Health and Human Services (federal office) - Nenana Municipal Airport, AK (federal facility, mentioned in attachment but not directly related to device classification)

Description

The Food and Drug Administration (FDA) is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions into class II (special controls). This device consists of a light-emitting device and a photoconverter gel intended to employ light energy for reducing the appearance of acute post-surgical incisions. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens. The device is subject to premarket notification requirements under section 510(k) of the FD&C Act. The order is effective May 1, 2026, with classification applicable since December 3, 2021.

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