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

FDA 510(k)

Infrared Heat (Model: E0221)

K-Number: K223893 · 2023-05-16

ApplicantLight Tree Ventures Europe B.V.
Decision Date2023-05-16
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Infrared Heat (Model: E0221) is a medical device manufactured by Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2023-05-16 under approval number K223893. 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 Infrared Heat (Model: E0221)?

Infrared Heat (Model: E0221) is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Light Tree Ventures Europe B.V.. The 510(k) number is K223893.

When was Infrared Heat (Model: E0221) approved by the FDA?

Infrared Heat (Model: E0221) received FDA 510(k) clearance on 2023-05-16, under approval number K223893.

What company makes Infrared Heat (Model: E0221)?

Infrared Heat (Model: E0221) is manufactured by Light Tree Ventures Europe B.V..

What is the FDA product code for Infrared Heat (Model: E0221)?

The FDA product code for Infrared Heat (Model: E0221) is OHS.

Related Clinical Trials

NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING

Other Devices by Light Tree Ventures Europe B.V.

K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) K221444LED Eye Perfector, model: EY-36A, EY-36B K221946LED Light Therapy Mask (model: MK66R-B) K222205Cold Sore Device (Model: QPZ-01) K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

View all 13 devices →

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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.

↑