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

K-Number: K213558 · 2022-03-08

ApplicantUlike Co., Ltd.
Decision Date2022-03-08
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Ulike Co., Ltd.. It received FDA 510(k) clearance on 2022-03-08 under 510(k) number K213558. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL Hair Removal Device?

IPL Hair Removal Device is a medical device that received FDA 510(k) clearance on 2022-03-08. The listed applicant is Ulike Co., Ltd.. The 510(k) number is K213558.

When did IPL Hair Removal Device receive FDA 510(k) clearance?

IPL Hair Removal Device received FDA 510(k) clearance on 2022-03-08, under 510(k) number K213558.

Who is the listed applicant for IPL Hair Removal Device?

The FDA 510(k) record lists Ulike 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?

The FDA product code for IPL Hair Removal Device is ONF.

Other records listing Ulike 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.

K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)K221553Diamond Air+ (UI04A, UI04B, UI04C)

Related Devices (Code: ONF)

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T 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.

↑