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FDA 510(k)

MZ Skin LightMAX Supercharged LED Mask 2.0

K-Number: K213184 · 2021-11-23

ApplicantMz Skin
Decision Date2021-11-23
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MZ Skin LightMAX Supercharged LED Mask 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Mz Skin. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K213184. 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 MZ Skin LightMAX Supercharged LED Mask 2.0?

MZ Skin LightMAX Supercharged LED Mask 2.0 is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Mz Skin. The 510(k) number is K213184.

When did MZ Skin LightMAX Supercharged LED Mask 2.0 receive FDA 510(k) clearance?

MZ Skin LightMAX Supercharged LED Mask 2.0 received FDA 510(k) clearance on 2021-11-23, under 510(k) number K213184.

Who is the listed applicant for MZ Skin LightMAX Supercharged LED Mask 2.0?

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

What is the FDA product code for MZ Skin LightMAX Supercharged LED Mask 2.0?

The FDA product code for MZ Skin LightMAX Supercharged LED Mask 2.0 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

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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