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)

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

K-Number: K221466 · 2022-08-12

Decision Date2022-08-12
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K221466. 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, AI06, AI08, AI16, AI17?

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. The 510(k) number is K221466.

When did IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 receive FDA 510(k) clearance?

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221466.

Who is the listed applicant for IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17?

The FDA 510(k) record lists Shenzhen Century Dongyuan Technology CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17?

The FDA product code for IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 is OHT.

Other records listing Shenzhen Century Dongyuan 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.

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.

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.