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)

Oren LED Perioral Light Therapy System

K-Number: K213024 · 2021-12-22

Decision Date2021-12-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Oren LED Perioral Light Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213024. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oren LED Perioral Light Therapy System?

Oren LED Perioral Light Therapy System is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K213024.

When did Oren LED Perioral Light Therapy System receive FDA 510(k) clearance?

Oren LED Perioral Light Therapy System received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213024.

Who is the listed applicant for Oren LED Perioral Light Therapy System?

The FDA 510(k) record lists Shenzhen Kaiyan Medical CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oren LED Perioral Light Therapy System?

The FDA product code for Oren LED Perioral Light Therapy System is OHS.

Other records listing Shenzhen Kaiyan Medical CO , Ltd. as applicant

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.

Related Devices (Code: OHS)

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.

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.