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
00622356757744Shark™ CryoGlowFW322SL2026-10-19
10622356707562Shark™ CryoGlowFW312BPFW3122026-09-21
00622356753760Shark™ FacialPro Glow™FH3102026-08-17
00622356753937Shark™ FacialPro Glow™FH310PK2026-08-17
00622356759533Shark™ FacialPro Glow™FH310SAMBL12026-08-17
00622356746410Shark™ CryoGlow Plus™FW350PKFW3502026-08-01
00622356746526Shark™ CryoGlow Plus™FW350BL1FW3502026-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855264008695CamarAura MedicalOLP2026-10-22
00855264008695CamarAura MedicalOHS2026-10-22
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOLP2026-10-19
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOHS2026-10-19
00810045461632CapillusCAPILLUS, LLCOLP2026-10-19
00810045461632CapillusCAPILLUS, LLCOHS2026-10-19
00810050289252HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOHS2026-10-01
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOLP2026-10-01
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOLP2026-09-21
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOHS2026-09-21
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00622356753760Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356759533Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00860016300309LMNTXPLR LTDOHS2026-08-17
00860016300309LMNTXPLR LTDOLP2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14