FDA.reportPublic FDA data

Professional Red

Primary DI
00851478007103
Brand
Professional Red
Company
QUASAR BIO-TECH INC.
Model
DPA-004Red
Catalog number
DPA-004Red
Device description
The Quasar Professional Red Light Therapy device enables you to provide essential treatments to rebuild clients’ collagen and elastin. Smooth the skin and reduce wrinkles with the most powerful tools available outside the doctors’ offices.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130225000QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICESilverbay, LLC, D/B/A Quasar Bio-Tech2013-07-11OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851478007103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851478007103008514780071038514780071030851478007103

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
941-306-5812denette@quasarbiotech.com

Regulatory Flags#

DUNS number
849862912
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851478007042Baby BlueDPA-002DPA-0022016-09-19
00851478007059Baby Blue PinkDPA-002-PKDPA-002-PK2016-09-19
00851478007080Quasar MD BlueDPA-022DPA-0222016-09-19
00851478007097Quasar MD Blue PinkDPA-022-PKDPA-022-PK2016-09-19
00851478007110Professional BlueDPA-006ADPA-006A2016-09-19
00851478007196Clear Rayz for Him StormyDPA-021-StormyDPA-021-Stormy2016-09-19
00851478007202Clear Rayz for Him TitaniumDPA-021-TitaniumDPA-021-Titanium2016-09-19
00851478007219Clear Rayz for Him WHDPA-021-Him/WHDPA-021-Him/WH2016-09-19
00851478007226Healing RayzDPA-027DPA-0272016-09-19
00851478007004Baby Quasar PlusDPA-023DPA-0232016-09-19
00851478007011Baby Quasar Plus PinkDPA-023-PKDPA-023-PK2016-09-19
00851478007028Baby Quasar Plus TealDPA-023-TealDPA-023-Teal2016-09-19
00851478007035Baby Quasar Plus 14KDPA-023-GoldDPA-023-Gold2016-09-19
00851478007066Quasar MD PlusDPA-024DPA-0242016-09-19
00851478007073Quasar MD Plus PinkDPA-024-PKDPA-024-PK2016-09-19
00851478007127Pure Rayz WhiteDPA-026-WHDPA-026-WH2016-09-19
00851478007134Pure Rayz PinkDPA-026-PRPKDPA-026-PRPK2016-09-19
00851478007141Pure Rayz TealDPA-026-PRTEALDPA-026-PRTEAL2016-09-19
00851478007158Pure Rayz for Him - SageDPA-026-SageDPA-026-Sage2016-09-19
00851478007165Pure Rayz for Him - ReflectingDPA-026-ReflectingDPA-026-Reflecting2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
06980088700006KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990143NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990167NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990174NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990181NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06974958310549ideatherapyShenzhen Idea Light LimitedOHS2026-04-17
06974958310556LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06974958310563LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07