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)

Hee HR Mini

K-Number: K170269 · 2017-05-03

ApplicantOriental Inspiration Limited
Decision Date2017-05-03
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Hee HR Mini is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K170269. 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 Hee HR Mini?

Hee HR Mini is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K170269.

When did Hee HR Mini receive FDA 510(k) clearance?

Hee HR Mini received FDA 510(k) clearance on 2017-05-03, under 510(k) number K170269.

Who is the listed applicant for Hee HR Mini?

The FDA 510(k) record lists Oriental Inspiration Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hee HR Mini?

The FDA product code for Hee HR Mini is OHT.

Other records listing Oriental Inspiration Limited 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.

K233046Electrical Neuromuscular Stimulator, Cure TrioK213133Keffort (MC-100, MC-100A)K212285Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)K170260BC-001+ Acne Purifier

Related Devices (Code: OHT)

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.

K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)Shenzhen Semlamp Intelligent Technology Co., Ltd.K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)Shenzhen Chuangtong Yigou 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.

↑