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)

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)

K-Number: K242197 · 2024-10-17

Decision Date2024-10-17
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is a medical device manufactured by Shenzhen Huaruibo Electric Appliances Co., Ltd.. It received FDA 510(k) clearance on 2024-10-17 under approval number K242197. 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 IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is a medical device that received FDA 510(k) clearance on 2024-10-17. It is manufactured by Shenzhen Huaruibo Electric Appliances Co., Ltd.. The 510(k) number is K242197.

When was IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) approved by the FDA?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) received FDA 510(k) clearance on 2024-10-17, under approval number K242197.

What company makes IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is manufactured by Shenzhen Huaruibo Electric Appliances Co., Ltd..

What is the FDA product code for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

The FDA product code for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is OHT.

Related Clinical Trials

Related Devices (Code: OHT)

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.