Decision Date2017-08-11
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Silk'n Infinity is the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K171433. 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 Silk'n Infinity?
Silk'n Infinity is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K171433.
When did Silk'n Infinity receive FDA 510(k) clearance?
Silk'n Infinity received FDA 510(k) clearance on 2017-08-11, under 510(k) number K171433.
Who is the listed applicant for Silk'n Infinity?
The FDA 510(k) record lists Home Skinovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Silk'n Infinity?
The FDA product code for Silk'n Infinity is OHT.
Other records listing Home Skinovations , 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: 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.