FDA.reportPublic FDA data

Clear Rayz for Him Titanium

Primary DI
00851478007202
Brand
Clear Rayz for Him Titanium
Company
QUASAR BIO-TECH INC.
Model
DPA-021-Titanium
Catalog number
DPA-021-Titanium
Device description
No matter what your age, skin type, or skin tone, the blue and red lights treat and heal acne anywhere on your body.
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
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111286000QUASAR CALYPSOSilver Bay, LLC2012-01-18OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851478007202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851478007202008514780072028514780072020851478007202

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable mains electricity (AC-powered) device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). It is normally available [non-prescription] over-the-counter (OTC) for use by the patient in the home or by a healthcare professional in a clinical setting.

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
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
00851478007103Professional RedDPA-004RedDPA-004Red2016-09-19
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 LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OLP2026-05-28
18712856075024Silk'nSilkn Beauty Ltd.OLP2026-05-07
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990198NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990204NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990211NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990228NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06977168990334NuonShenzhen Nuon Medical Equipment Co., Ltd.OLP2026-04-21
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOLP2026-04-07
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OLP2026-03-26
07640260120600FAQ LED PanelForeo ABOLP2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
06979826590115PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590122PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590139PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590146PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590153PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590160PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590177PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26
06979826590184PMDDongguan Hunter Electronic Technology Co., Ltd.OLP2026-02-26