Decision Date2018-02-28
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
REVIAN RED is the device name listed in this FDA 510(k) record. The listed applicant is Photonmd, Inc.. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K173729. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REVIAN RED?
REVIAN RED is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Photonmd, Inc.. The 510(k) number is K173729.
When did REVIAN RED receive FDA 510(k) clearance?
REVIAN RED received FDA 510(k) clearance on 2018-02-28, under 510(k) number K173729.
Who is the listed applicant for REVIAN RED?
The FDA 510(k) record lists Photonmd, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REVIAN RED?
The FDA product code for REVIAN RED is OAP.
Related Devices (Code: OAP)
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.
K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK251684Alma TED+ SystemAlma Lasers, Inc.K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment 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.