CONTACT LENS CLEANING ACCESSORY— 510(k) K923816

Name: FDA 510(k) clearance K923816
Creator: U.S. Food and Drug Administration
Published: 1993-03-08

Substantially Equivalent

Cramer Ent., Inc.

FDA 510(k) clearance K923816 for CONTACT LENS CLEANING ACCESSORY, Substantially Equivalent on 1993-03-08. Applicant: Cramer Ent., Inc.. Device class: 2.

Clearance details

Applicant: Cramer Ent., Inc.
Product code: Code LYL
Device class: Class 2
Regulation: 21 CFR 886.5928
Advisory panel: Ophthalmic
Date received: 1992-07-30
Decision date: 1993-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYL

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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

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.