Submission Details
| 510(k) Number | K020802 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2002 |
| Decision Date | May 31, 2002 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
May 2002
Decision
80d
Days
Class 2
Risk
About This 510(k) Submission
K020802 is an FDA 510(k) clearance for the RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION, a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II — Special Controls, product code LYL), submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on May 31, 2002, 80 days after receiving the submission on March 12, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LYL — Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
Similar Devices — LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
All 21
K211361 · Suzhou 3N Biological Technology Co., Ltd.
· Jan 2022
K210300 · Vuesonic, LLC
· Apr 2021
K083757 · Bausch & Lomb, Inc.
· Nov 2009
K021699 · Autolens, Inc.
· Dec 2002
K022687 · Ciba Vision Corporation
· Nov 2002
K994021 · Strieter Clinical Research Laboratories, Inc.
· Feb 2000
More from Bausch & Lomb, Incorporated
View all
K242389
· MSS · Oct 2024
K230954
· LPL · Nov 2023
K220613
· LPL · Mar 2023
K222541
· LPN · Dec 2022
K211786
· LYX · Dec 2021