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)

Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine

K-Number: K210545 · 2022-05-20

ApplicantMarci Beauty, Inc.
Decision Date2022-05-20
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine is the device name listed in this FDA 510(k) record. The listed applicant is Marci Beauty, Inc.. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K210545. 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 Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine?

Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is Marci Beauty, Inc.. The 510(k) number is K210545.

When did Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine receive FDA 510(k) clearance?

Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine received FDA 510(k) clearance on 2022-05-20, under 510(k) number K210545.

Who is the listed applicant for Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine?

The FDA 510(k) record lists Marci Beauty, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine?

The FDA product code for Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine 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.

NCT07370051Effect of Topical Oxygen and LED Light Therapy on Nipple CrackNOT_YET_RECRUITINGNCT07450716Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of PruritusNOT_YET_RECRUITINGNCT05710705Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast ReconstructionRECRUITINGNCT05926011Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's DiseaseRECRUITINGNCT06068959Photobiomodulation on Pain in Patients With Temporomandibular DysfunctionCOMPLETEDNCT06913309Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive DisorderRECRUITING

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 CorporationK242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED 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.

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.

↑