Cleared Traditional

PuriLens Plus Preservative Free Saline

K200747 · The Lifestyle Company, Inc. · Ophthalmic

May 2020

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K200747 is an FDA 510(k) clearance for the PuriLens Plus Preservative Free Saline, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by The Lifestyle Company, Inc. (Freehold, US). The FDA issued a Cleared decision on May 15, 2020, 53 days after receiving the submission on March 23, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K200747 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2020
Decision Date	May 15, 2020
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF