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)

IVYLASER Handhold Hair Removal Machine

K-Number: K230025 · 2023-07-03

ApplicantIvylaser (Beijing) Technology Co.,Ltd
Decision Date2023-07-03
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IVYLASER Handhold Hair Removal Machine is a medical device manufactured by Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-07-03 under approval number K230025. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVYLASER Handhold Hair Removal Machine?

IVYLASER Handhold Hair Removal Machine is a medical device that received FDA 510(k) clearance on 2023-07-03. It is manufactured by Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K230025.

When was IVYLASER Handhold Hair Removal Machine approved by the FDA?

IVYLASER Handhold Hair Removal Machine received FDA 510(k) clearance on 2023-07-03, under approval number K230025.

What company makes IVYLASER Handhold Hair Removal Machine?

IVYLASER Handhold Hair Removal Machine is manufactured by Ivylaser (Beijing) Technology Co.,Ltd.

What is the FDA product code for IVYLASER Handhold Hair Removal Machine?

The FDA product code for IVYLASER Handhold Hair Removal Machine is OHT.

Related Clinical Trials

NCT07595198 Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction NOT_YET_RECRUITING NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING NCT06832696 Assessment of a Wearable Ultrafiltration Device NOT_YET_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING

Other Devices by Ivylaser (Beijing) Technology Co.,Ltd

K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy) K250206Diode laser system (Night Universe; Predator)

Related Devices (Code: OHT)

K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expertCyden Limited K161089sensiLight MiniEl Global Trade, Ltd. K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited K172181micro IPLEl Global Trade, Ltd. K171433Silk'n InfinityHome Skinovations , Ltd. K170269Hee HR MiniOriental Inspiration Limited

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.

↑