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FDA 510(k)

Shani Darden LED light therapy mask

K-Number: K214103 · 2022-03-22

ApplicantHarpar Grace International
Decision Date2022-03-22
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Shani Darden LED light therapy mask is the device name listed in this FDA 510(k) record. The listed applicant is Harpar Grace International. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K214103. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shani Darden LED light therapy mask?

Shani Darden LED light therapy mask is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Harpar Grace International. The 510(k) number is K214103.

When did Shani Darden LED light therapy mask receive FDA 510(k) clearance?

Shani Darden LED light therapy mask received FDA 510(k) clearance on 2022-03-22, under 510(k) number K214103.

Who is the listed applicant for Shani Darden LED light therapy mask?

The FDA 510(k) record lists Harpar Grace International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shani Darden LED light therapy mask?

The FDA product code for Shani Darden LED light therapy mask is OLP.

Related Clinical Trials

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.

NCT07661004Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .NOT_YET_RECRUITING

Related Devices (Code: OLP)

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.

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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