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

GMDN Terms#

Term, Definition table
TermDefinition
Contact lens agitation cleaning system, mechanicalAn assembly of devices used to clean and disinfect contact lenses through automated or manual mechanical agitation (e.g., spinning, shaking, wiping). It may consist of a reservoir to hold contact lens solution and the lenses, a base, a cap, and additional components, however other configurations are possible. Some assemblies may include an ultraviolet (UV) radiation source.

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
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
00830002000049PuriLens Plus Disinfecting System Cleaning ChamberLIFESTYLE CO INC, THELYL2021-09-24