PuriLens Plus Preservative Free Saline

Q: What is the product code of K200747?

The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.

FDA 510(k) K200747 · The Lifestyle Company, Inc.

Substantially Equivalent

510(k) numberK200747

Submission

Device name: PuriLens Plus Preservative Free Saline
Applicant: The Lifestyle Company, Inc.
Freehold, NJ, US
Received: March 23, 2020
Decision date: May 15, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LPN – Accessories, Soft Lens Products
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.5928
Specialty: Ophthalmic

Other 510(k)s with product code LPN

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K253795	MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional	Menicon Co, Ltd.	08/13/2026SE
K222541	Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional	Bausch & Lomb, Incorporated	12/06/2022SE
K221263	Aqua Naina Plus Sterile Saline SolutionLPN · Special	Chemtex USA, Inc.	10/12/2022SE
K202932	ABT12 multi-purpose solutionLPN · Traditional	Bausch & Lomb, Incorporated	05/28/2021SE
K210051	OTE MPS 045 Multi-purpose Lens Care SolutionLPN · Traditional	Ote North America, LLC	05/26/2021SE
K193441	Aqua Naina Sterile Saline SolutionLPN · Traditional	Chemtex USA, Inc.	05/26/2020SE
K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional	Menicon Co, Ltd.	03/02/2020SE
K190674	REFRESH RELIEVA For CONTACTSLPN · Traditional	Allergan, Inc.	08/08/2019SE
K191795	AOCup Lens Case with AODiscLPN · Special	Alcon Laboratories, Inc.	07/31/2019SE
K170483	Bausch + Lomb Sensitive Eyes Plus Saline SolutionLPN · Traditional	Bausch & Lomb, Incorporated	04/11/2017SE

More from Bausch & Lomb, Incorporated

510(k)	Device	Decision
K000529	Lifestyle MV2 (TM) Toric (Polymacon) Soft (Hydrophilic) Multifocal Contact Lens for…LPL · Traditional	03/21/2000SE
K965012	Lifestyle Break Thru (Polymacon)LPL · Traditional	03/11/1997SE

Questions and answers

When was PuriLens Plus Preservative Free Saline cleared by the FDA?

PuriLens Plus Preservative Free Saline (K200747) received a 510(k) decision of Substantially Equivalent on May 15, 2020, 53 days after the submission was received.

What is the product code of K200747?

The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.