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Pra.L Derma LED Mask

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183671

by LG Electronics Inc.

Identifiers

510(k) Number
K183671 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 Pra.L Derma LED Mask is a light-based device classified as an Over-the-Counter Wrinkle Reduction device, designed to target full-face wrinkles. It employs LED technology to deliver targeted light therapy for skin rejuvenation, addressing superficial aging signs without invasive procedures.

This device is intended for home use and is supplied as a reusable, non-sterile product. It requires no special storage conditions beyond a cool, dry environment and is cleared for use under FDA 510(k) K183671. Maintenance involves wiping the face-contact area with water or a damp cloth when soiled. The device is classified under regulation number 878.4810 and is not intended for clinical or professional medical settings.

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. Sources consulted: LG Launches Popular Korean Home Beauty Devices Pra.L Series ... - LG USA, LG PRA.L DERMA LED MASK - SkinCarisma, LG PRA.L DERMA LED MASK (K183671) — FDA 510 (k) | Innolitics, Derma LED Mask

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
LG Electronics Inc.
FDA Applicant
Lg Electronics.Inc

Sources (1)

  • FDA 510(k) K183671 24 fields · synced Sep 20, 2026