FDA.reportPublic FDA data

PuriLens Plus Disinfecting System Exchange Kit

Primary DI
00830002000056
Brand
PuriLens Plus Disinfecting System Exchange Kit
Company
LIFESTYLE CO INC, THE
Model
MS0610/H
Device description
Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
Published
2021-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYLAccessories, Solution, Ultrasonic Cleaners For Lenses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYLAccessories, Solution, Ultrasonic Cleaners For LensesOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991965000PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSESPurilens, Inc.1999-10-01LYL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00830002000056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00830002000056008300020000568300020000560830002000056

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006220777lenses@lifestylecompany.com

Regulatory Flags#

DUNS number
946065000
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00830002001015SGPtelefocon A2017-09-24
00830002002012SGP IItelefocon B2017-09-24
00830002003019SGP 3unifocon A2017-09-24
00830002000018PuriLens Plus Preservative Free Saline4 oz. (120 mL) Bottle2021-09-24
00830002000094PuriLens Plus Preservative Free Saline2 oz. (60 mL) Bottle2021-09-24
00830002000032PuriLens Plus Disinfecting System Lens BasketMS0610/H2021-09-24
00830002000049PuriLens Plus Disinfecting System Cleaning ChamberMS0610/H2021-09-24
00830002000063PuriLens Plus Disinfecting SystemMS0610/H2021-09-24
00830002000070PuriLens Plus Disinfecting System 110V AdapterMS0610/H2021-09-24
00830002000087PuriLens Plus Preservative Free Saline4 oz. (120 mL) Bottle2021-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195515153294Amazon BasicsAMAZON.COM SERVICES LLCLYL2026-08-07
00310119041024Bausch + LombBausch & Lomb IncorporatedLYL2026-01-09
00310119041406Bausch + LombBausch & Lomb IncorporatedLYL2026-01-09
00713733806695MeijerMEIJER, INC.LYL2024-12-16
00713733806701MeijerMEIJER, INC.LYL2024-12-16
00713733806718MeijerMEIJER, INC.LYL2024-12-16
00713733806886MeijerMEIJER, INC.LYL2024-12-16
00310119304488Target moisture balance advanced multi-purpose solutionTARGET CORPORATIONLYL2024-07-16
00310119304471WalgreensWALGREEN CO.LYL2024-07-01
00078742321738Member's MarkWAL-MART STORES, INC.LYL2024-04-15
00310119041222Member's MarkWAL-MART STORES, INC.LYL2024-04-15
00846036009606Good SenseGEISS, DESTIN & DUNN, INCLYL2024-02-13
00195515043182Amazon Basic Care AMAZON.COM SERVICES LLCLYL2023-12-12
00195515043199Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
00195515043175Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
10195515043189Amazon Basic Care AMAZON.COM SERVICES LLCLYL2023-12-12
10195515043196Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
00195515043205Amazon Basic CareAMAZON.COM SERVICES LLCLYL2023-12-12
00095072049552DG Health DOLGENCORP, LLCLYL2023-09-18
00095072100048DG Health DOLGENCORP, LLCLYL2023-09-18
00087701431982Good NeighborAmerisourcebergen Drug CorporationLYL2023-09-12
00087701190100Good NeighborAmerisourcebergen Drug CorporationLYL2023-09-11
00050428395127CVS HEALTH WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLYL2023-09-08
00311917011936WalgreensWALGREEN CO.LYL2022-05-24
00311917011943WalgreensWALGREEN CO.LYL2022-05-24
00311917012018WalgreensWALGREEN CO.LYL2022-05-24
10311917011933WalgreensWALGREEN CO.LYL2022-05-24
20311917011947WalgreensWALGREEN CO.LYL2022-05-24
20311917012012WalgreensWALGREEN CO.LYL2022-05-24
00830002000032PuriLens Plus Disinfecting System Lens BasketLIFESTYLE CO INC, THELYL2021-09-24