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FDA 510(k)

IPL Hair Removal Device, model: AI01

K-Number: K212897 · 2021-11-04

ApplicantShenzhen Century Dongyuan Technology CO , Ltd.
Decision Date2021-11-04
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, model: AI01 is a medical device manufactured by Shenzhen Century Dongyuan Technology CO , Ltd.. It received FDA 510(k) clearance on 2021-11-04 under approval number K212897. 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, model: AI01?

IPL Hair Removal Device, model: AI01 is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Shenzhen Century Dongyuan Technology CO , Ltd.. The 510(k) number is K212897.

When was IPL Hair Removal Device, model: AI01 approved by the FDA?

IPL Hair Removal Device, model: AI01 received FDA 510(k) clearance on 2021-11-04, under approval number K212897.

What company makes IPL Hair Removal Device, model: AI01?

IPL Hair Removal Device, model: AI01 is manufactured by Shenzhen Century Dongyuan Technology CO , Ltd..

What is the FDA product code for IPL Hair Removal Device, model: AI01?

The FDA product code for IPL Hair Removal Device, model: AI01 is OHT.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Shenzhen Century Dongyuan Technology CO , Ltd.

K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17

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.

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