FDA.reportPublic FDA data

FacialPro Glow

Primary DI
00622356642804
Brand
FacialPro Glow
Company
SharkNinja Operating LLC
Model
FH320
Device description
FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00622356642804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00622356642804006223566428046223566428040622356642804

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
144444333
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00622356646390Shark CryoGlowFW3022026-06-02
00622356663076Shark CryoGlowFW3222026-06-02
00622356669351Shark CryoGlowFW312PL2026-06-02
00622356669597Shark CryoGlowFW302PL2026-06-02
00622356691161Shark FacialPro GlowFH3202026-06-02
00622356699631Shark FacialPro GlowFH320BK2026-06-02
00622356703048Shark FacialPro GlowFH320PL2026-06-02
00622356704885Shark™ DePuffi™FH220TL2026-06-02
00622356704953Shark™ DePuffi™FH220PK2026-06-02
00622356706926Shark CryoGlowFW332COPL2026-06-02
00622356710664Shark FacialPro GlowFH320GN2026-06-02
00622356710718Shark FacialPro GlowFH320PK2026-06-02
00622356712200Shark™ DePuffi™FH220BK2026-06-02
00622356736633Shark FacialPro GlowFH320COPU2026-06-02
10622356642801Shark CryoGlowFW3122026-06-02
00622356086912SharkCryoGlow2025-01-27

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088095244977763H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
088095244977833H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
00671152103873Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
00671152104788Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00810140063052RenphoJoicom CorporationIRT2026-06-23
00810140063069RenphoJoicom CorporationIRT2026-06-23
00810140063090RenphoJoicom CorporationOHS2026-06-23
00810140063090RenphoJoicom CorporationOLP2026-06-23
08809851470145WavefacialWEERO Co., Ltd.IRT2026-06-22
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
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00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02