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FDA 510(k)

reVive Light Therapy LED Cleansing System

K-Number: K180447 · 2018-06-04

ApplicantLed Technologies, Inc.
Decision Date2018-06-04
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

reVive Light Therapy LED Cleansing System is the device name listed in this FDA 510(k) record. The listed applicant is Led Technologies, Inc.. It received FDA 510(k) clearance on 2018-06-04 under 510(k) number K180447. 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 reVive Light Therapy LED Cleansing System?

reVive Light Therapy LED Cleansing System is a medical device that received FDA 510(k) clearance on 2018-06-04. The listed applicant is Led Technologies, Inc.. The 510(k) number is K180447.

When did reVive Light Therapy LED Cleansing System receive FDA 510(k) clearance?

reVive Light Therapy LED Cleansing System received FDA 510(k) clearance on 2018-06-04, under 510(k) number K180447.

Who is the listed applicant for reVive Light Therapy LED Cleansing System?

The FDA 510(k) record lists Led Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for reVive Light Therapy LED Cleansing System?

The FDA product code for reVive Light Therapy LED Cleansing System is OLP.

Other records listing Led Technologies, Inc. as applicant

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K223482reVive Light Therapy® Wrinkle and Acne LED DeviceK221430reVive Light Therapy LED Cleansing SystemK210968reVive Light Therapy EssentialsK210965reVive Light Therapy EssentialsK183247dpl FacewareK183118dpl SpotLite

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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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