Decision Date2022-08-31
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
IPL sapphire ice cooling hair remove device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Desida Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221635. 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 sapphire ice cooling hair remove device?
IPL sapphire ice cooling hair remove device is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is Shenzhen Desida Technology Co., Ltd.. The 510(k) number is K221635.
When did IPL sapphire ice cooling hair remove device receive FDA 510(k) clearance?
IPL sapphire ice cooling hair remove device received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221635.
Who is the listed applicant for IPL sapphire ice cooling hair remove device?
The FDA 510(k) record lists Shenzhen Desida Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IPL sapphire ice cooling hair remove device?
The FDA product code for IPL sapphire ice cooling hair remove device is OHT.
Other records listing Shenzhen Desida Technology Co., 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.
K254079LED Light Therapy Mask (Models: T2, RLD10)K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)K221643Hair Removal Device (Model: IPL-D26, IPL-D19)
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.