PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES— 510(k) K991965

Name: FDA 510(k) clearance K991965
Creator: U.S. Food and Drug Administration
Published: 1999-10-01

Substantially Equivalent

Purilens, Inc.

FDA 510(k) clearance K991965 for PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES, Substantially Equivalent on 1999-10-01. Applicant: Purilens, Inc.. Device class: 2.

Clearance details

Applicant: Purilens, Inc.
Product code: Code LYL
Device class: Class 2
Regulation: 21 CFR 886.5928
Advisory panel: Ophthalmic
Date received: 1999-06-10
Decision date: 1999-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYL

view all

K211361 — 3N Contact Lenses Adjunct Cleaner2022-01-13
K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System2021-04-01
K083757 — BPZ02 MULTIPURPOSE SOLUTION2009-11-18
K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT2002-12-16
K022687 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION2002-11-19

More clearances from Purilens, Inc.

view all

K002319 — PURILENS SALINE SOLUTION2000-08-30

Adverse events under product code LYL

product code LYL

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.