Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LED Light Therapy Mask (RT01)

K-Number: K242068 · 2025-04-04

ApplicantNingbo Dechang Electrical Machinery Made Co.,Ltd
Decision Date2025-04-04
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Mask (RT01) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dechang Electrical Machinery Made Co.,Ltd. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242068. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Light Therapy Mask (RT01)?

LED Light Therapy Mask (RT01) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Ningbo Dechang Electrical Machinery Made Co.,Ltd. The 510(k) number is K242068.

When did LED Light Therapy Mask (RT01) receive FDA 510(k) clearance?

LED Light Therapy Mask (RT01) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242068.

Who is the listed applicant for LED Light Therapy Mask (RT01)?

The FDA 510(k) record lists Ningbo Dechang Electrical Machinery Made Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (RT01)?

The FDA product code for LED Light Therapy Mask (RT01) is OLP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07661004Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .NOT_YET_RECRUITING

Related Devices (Code: OLP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑