Atlas FDA

RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION

FDA 510(k) clearance K020802 · decided 2002-05-31

Clearance details

K-number
K020802
Device name
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
Applicant
Bausch & Lomb, Incorporated
Decision
Substantially Equivalent
Date received
2002-03-12
Decision date
2002-05-31
Days to decision
80 days
Clearance type
Traditional
Product code
LYL
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Bausch & Lomb

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
3N Contact Lenses Adjunct Cleaner (K211361)Suzhou 3N Biological Technology Co., Ltd.2022-01-13
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System (K210300)Vuesonic, LLC2021-04-01
BPZ02 MULTIPURPOSE SOLUTION (K083757)Bausch & Lomb, Inc.2009-11-18
AUTOLENS CLEANING AND DISINFECTING UNIT (K021699)Autolens, Inc.2002-12-16
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K022687)Ciba Vision Corporation2002-11-19
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021)Strieter Clinical Research Laboratories, Inc.2000-02-22
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (K991965)Purilens, Inc.1999-10-01
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (K982115)Rim-Wide Companies, Inc.1999-01-13
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT (K974724)Lens Comfort, Inc.1998-03-02
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (K964222)Paladin Medical, Inc.1996-12-20
NEW COMFORT CONTACT LENS CARE ACCESSORY (K962112)Lens Comfort, Inc.1996-11-29
OPTI PADS (K950940)Karlen Mfg., Inc.1995-06-26

Recalls involving this device

RecordFirmDate
Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distri recall (Z-3042-2011)Bausch & Lomb Inc2011-08-19
Contact lens solution. The product is distributed under the following trade names: Bausch recall (Z-0715-2007)Bausch & Lomb Inc2007-04-04

PMA approvals by this applicant

RecordFirmDate
XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080021)Bausch & Lomb, Incorporated2009-02-02