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510(k) K242068

LED Light Therapy Mask (RT01) by Ningbo Dechang Electrical Machinery Made Co.,Ltd — Product Code OLP

K242068 is an FDA 510(k) premarket notification submitted by Ningbo Dechang Electrical Machinery Made Co.,Ltd for the device "LED Light Therapy Mask (RT01)". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code OLP (Over-The-Counter Powered Light Based Laser For Acne), a Class II device regulated under 21 CFR 878.4810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
July 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Powered Light Based Laser For Acne
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

Other clearances for product code OLP

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  • K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, (February 5, 2025)
  • K232656 — BLU TOTALE (Model: ENEOB852) (November 14, 2023)
  • K230490 — PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-N (October 27, 2023)
  • K230720 — LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 (July 3, 2023)
  • K213056 — LED Facial Mask (July 7, 2022)
  • K220729 — The Luminance RED Acne Device (June 9, 2022)
  • K213039 — Micro-current facial cold and hot service (model: TPML-100) (May 25, 2022)
  • K210545 — Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light hea (May 20, 2022)

FDA data resources