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 (Model: SL-B080, SL-B126, SL-B136)

K-Number: K221246 · 2022-07-07

ApplicantShenzhen Semlamp Intelligent Technology Co., Ltd.
Decision Date2022-07-07
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is a medical device manufactured by Shenzhen Semlamp Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-07 under approval number K221246. 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 (Model: SL-B080, SL-B126, SL-B136)?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is a medical device that received FDA 510(k) clearance on 2022-07-07. It is manufactured by Shenzhen Semlamp Intelligent Technology Co., Ltd.. The 510(k) number is K221246.

When was IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) approved by the FDA?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) received FDA 510(k) clearance on 2022-07-07, under approval number K221246.

What company makes IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is manufactured by Shenzhen Semlamp Intelligent Technology Co., Ltd..

What is the FDA product code for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

The FDA product code for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is OHT.

Related Clinical Trials

NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT05593523 Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes ACTIVE_NOT_RECRUITING

Other Devices by Shenzhen Semlamp Intelligent Technology Co., Ltd.

K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) 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)

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.

↑