B.Light Clear Evo and B.Light Restore Evo

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223919

Identifiers

510(k) Number: K223919 FDA 510(k)
FDA Product Code: OHS FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The B.Light Clear Evo and B.Light Restore Evo are light-based devices designed for over-the-counter wrinkle reduction. Classified as Light-Based Over The Counter Wrinkle Reduction devices, they employ phototherapy to target skin rejuvenation and improvement of fine lines and wrinkles through controlled light exposure.

These devices are intended for home use and are supplied as non-invasive, reusable systems. They comply with FDA 510K clearance, MDD, and MDR regulations, with a classification under device code OHS. The devices are not sterile and are intended for single-user application, requiring proper storage in a clean, dry environment to maintain functionality. No MRI safety information is specified.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K223919	Class II	Active

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Manufacturer

Manufacturer: Bemer Int. AG
FDA Applicant: Bemer Int AG

Sources (2)

FDA 510(k) K223919 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026