Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2249258

FEI Number

3002224304

Entity Name

THE LIFESTYLE CO., INC.

City/State/Country

Freehold, NJ, US

Establishment Address

6 Paragon Way Ste 112, Freehold, NJ 07728, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

The LifeStyle Company, Inc. (Owner Number: 9035196)

Owner / Operator Contact Address

6 Paragon Way, Suite 112, Freehold, NJ 07728, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200747

PMA Number

N/A

All Registered Proprietary Names

PuriLens Plus Preservative Free Saline

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRC	Products, Contact Lens Care, Rigid Gas Permeable	Ophthalmic	Class 2	886.5918	2020-10-02
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2020-10-02

Official Correspondent

Arthur Blake III

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The LifeStyle Company, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2022	Contamac Solutions, Inc.	2	Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Z-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.
Z-0130-2011	Abbott Medical Optics Inc (AMO)	2	AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.

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3003093882	NIAGARA PHARMACEUTICALS, INC.	Dundas Ontario, CA
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2249258. Last updated year: 2026. Please use registration number 2249258 when referencing this establishment in official correspondence.