Product Code: LPN FDA class 2 21 CFR 886.5928

Accessories, Soft Lens Products

Ophthalmic

Soft lens product accessories are ancillary items used in conjunction with soft contact lenses, such as lens cases, cleaning solutions, and related care products that facilitate safe contact lens use and maintenance. They are classified as a Class 2 (moderate risk) device, subject to general and special controls, and require 510(k) premarket notification before marketing. The product code is LPN, regulated under 21 CFR 886.5928, within the Ophthalmic medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

120

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LPN
Device Class: FDA class 2
Regulation Number: 886.5928
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 120 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222541	Bausch + Lomb Preservative Free Lubricating and Rewetting Drops	Dec 06, 2022	Substantially Equivalent	Bausch & Lomb Incorporated
K221263	Aqua Naina Plus Sterile Saline Solution	Oct 12, 2022	Substantially Equivalent	Chemtex USA Inc.
K202932	ABT12 multi-purpose solution	May 28, 2021	Substantially Equivalent	Bausch & Lomb Incorporated
K210051	OTE MPS 045 Multi-purpose Lens Care Solution	May 26, 2021	Substantially Equivalent	OTE North America LLC
K193441	Aqua Naina Sterile Saline Solution	May 26, 2020	Substantially Equivalent	Chemtex USA, Inc.
K200747	PuriLens Plus Preservative Free Saline	May 15, 2020	Substantially Equivalent	The LifeStyle Company, Inc.
K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	Mar 02, 2020	Substantially Equivalent	Menicon Co., Ltd.
K190674	REFRESH RELIEVA For CONTACTS	Aug 08, 2019	Substantially Equivalent	Allergan, Inc
K191795	AOCup Lens Case with AODisc	Jul 31, 2019	Substantially Equivalent	Alcon Laboratories, Inc.
K170483	Bausch + Lomb Sensitive Eyes Plus Saline Solution	Apr 11, 2017	Substantially Equivalent	Bausch & Lomb Incorporated
K161819	NNR06 Multi-Purpose Solution	Nov 25, 2016	Substantially Equivalent	Bausch & Lomb Incorporated
K162597	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	Oct 19, 2016	Substantially Equivalent	Alcon Laboratories, Inc.
K161622	LensGiene Sterile Saline Solution	Aug 11, 2016	Substantially Equivalent	Optics Laboratory, Inc.
K151768	Menicon Saline Rinse Solution	Aug 28, 2015	Substantially Equivalent	MENICON CO.,LTD.
K142284	CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE	Jan 26, 2015	Substantially Equivalent	ALCON LABORATORIES, INC.
K132216	BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION	Sep 09, 2013	Substantially Equivalent	BAUSCH & LOMB INCORPORATED
K130734	SAUFLON MULTIPURPOSE SOLUTION	May 15, 2013	Substantially Equivalent	SAUFLON PHARMACEUTICALS, LTD.
K112909	OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION	Apr 30, 2012	Substantially Equivalent	BAUSCH & LOMB, INC.
K111877	EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION	Jan 24, 2012	Substantially Equivalent	BAUSCH & LOMB, INC.
K110221	EYE-CEPT STERILE SALINE SOLUTION	Nov 01, 2011	Substantially Equivalent	OPTICS LABORATORY, INC
K102860	ALCON MULTI-PIRPOSE DISINFECTING SOLUTION	May 10, 2011	Substantially Equivalent	ALCON RESEARCH, LTD.
K102165	STERILE SALINE SOLUTION	Jan 19, 2011	Substantially Equivalent	CACHET PHARMACEUTICALS PVT. LTD.
K093254	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	Sep 15, 2010	Substantially Equivalent	ABBOTT MEDICAL OPTICS INC
K093367	STERILE SALINE SOLUTION	Sep 10, 2010	Substantially Equivalent	CACHET PHARMACEUTICALS PVT. LTD.
K083812	REFRESH OPTIVE LENS COMFORT REWETTING DROPS	Jul 09, 2009	Substantially Equivalent	ALLERGAN, INC.
K071236	ALCON MULTI-PURPOSE SOLUTION	Dec 12, 2007	Substantially Equivalent	ALCON, INC.
K070767	EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION	Jul 24, 2007	Substantially Equivalent	LAPIS LAZULI INTERNATIONAL NV
K071203	SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES	Jun 13, 2007	Substantially Equivalent	OPTIKEM INTERNATIONAL, INC.
K062332	ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION	Apr 25, 2007	Substantially Equivalent	ALTAIRE PHARMACEUTICALS, INC.
K060924	JSZ MULTIACTION GP CONTACT LENS SOLUTION	Jun 28, 2006	Substantially Equivalent	SZABOCSIK AND ASSOCIATES
K051104	EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION	May 31, 2006	Substantially Equivalent	LAPIS LAZULI, NV
K050729	ALCON MULTI-PURPOSE DISINFECTING SOLUTION	Sep 14, 2005	Substantially Equivalent	ALCON RESEARCH, LTD.
K050250	AQUIFY MULTIPURPOSE SOLUTION	Aug 10, 2005	Substantially Equivalent	CIBA VISION CORPORATION
K042562	LENS PLUS REWETTING DROPS	Jul 29, 2005	Substantially Equivalent	ADVANCED MEDICAL OPTICS, INC.
K041008	EYE-CEPT REWETTING DROPS	Jul 01, 2005	Substantially Equivalent	OPTICS LABORATORY, INC.
K050517	JSZ-MULTIPURPOSE SOLUTION	Apr 13, 2005	Substantially Equivalent	SZABOCSIK AND ASSOCIATES
K042176	AQUIFY LENS COMFORT DROPS	Nov 03, 2004	Substantially Equivalent	CIBA VISION CORPORATION
K031753	KARATS MULTIPURPOSE SOLUTION	Oct 28, 2004	Substantially Equivalent	CIBA VISION CORPORATION
K033608	AQUIFY MULTI-PURPOSE SOLUTION	Feb 02, 2004	Substantially Equivalent	CIBA VISION CORPORATION
K031646	BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03	Nov 14, 2003	Substantially Equivalent	BAUSCH & LOMB, INC.
K032481	THERATEARS CONTACT LENS COMFORT DROPS	Nov 04, 2003	Substantially Equivalent	ADVANCED VISION RESEARCH, INC.
K030910	CLUED UP MULTIPURPOSE SOLUTION- NO RUB	Oct 10, 2003	Substantially Equivalent	CLUED UP LIMITED
K032030	BLINK CL LUBRICANT EYE DROPS	Sep 25, 2003	Substantially Equivalent	ADVANCED MEDICAL OPTICS, INC.
K030522	AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION	Sep 12, 2003	Substantially Equivalent	CIBA VISION CORPORATION
K031957	MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION	Aug 14, 2003	Substantially Equivalent	CIBA VISION CORPORATION
K030278	SAUFLON MULTIPURPOSE SOLUTION - NO RUB	Jul 30, 2003	Substantially Equivalent	SAUFLON PHARMACEUTICALS, LTD.
K031193	SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION	Jul 03, 2003	Substantially Equivalent	ALCON, INC.
K031522	SOLO-CARE PLUS MULTIPURPOSE SOLUTION	Jun 27, 2003	Substantially Equivalent	CIBA VISION CORPORATION
K031521	AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION	Jun 27, 2003	Substantially Equivalent	CIBA VISION CORPORATION
K030092	COMPLETE BRAND MULTI-PURPOSE SOLUTION	Apr 04, 2003	Substantially Equivalent	ADVANCED MEDICAL OPTICS, INC.
K021635	KARATS MULTIPURPOSE SOLUTION	Oct 28, 2002	Substantially Equivalent	CIBA VISION CORPORATION
K021143	OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION	Aug 08, 2002	Substantially Equivalent	ALCON UNIVERSAL, LTD.
K014202	COMPLETE BRAND MULTI-PURPOSE SOLUTION	Feb 20, 2002	Substantially Equivalent	ALLERGAN, INC.
K013479	COMPLETE BRAND MULTI-PURPOSE SOLUTION	Feb 11, 2002	Substantially Equivalent	ALLERGAN, INC.
K012731	SOLO-CARE PLUS MULTIPURPOSE SOLUTION	Dec 26, 2001	Substantially Equivalent	CIBA VISION CORPORATION
K013512	AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION	Dec 20, 2001	Substantially Equivalent	CIBA VISION CORPORATION
K010559	SAUFLON MULTI LENS CARE SYSTEM	Dec 20, 2001	Substantially Equivalent	SAUFLON PHARMACEUTICALS, LTD.
K011561	SEREINE EXTRA STRENGTH DAILY CLEANER	Nov 20, 2001	Substantially Equivalent	WILSA, INC.
K011796	RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION	Nov 01, 2001	Substantially Equivalent	BAUSCH & LOMB, INC.
K003345	AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION	Mar 26, 2001	Substantially Equivalent	CIBA VISION CORPORATION
K003252	COMPLETE BRAND MULTI-PURPOSE SOLUTION	Feb 21, 2001	Substantially Equivalent	ALLERGAN, INC.
K003031	LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML	Jan 05, 2001	Substantially Equivalent	ALPHA VISTA, INC.
K003109	COMPLETE BRAND LUBRICATING AND REWETTING DROPS	Nov 21, 2000	Substantially Equivalent	ALLERGAN, INC.
K002589	OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION	Oct 23, 2000	Substantially Equivalent	ALCON UNIVERSAL, LTD.
K002823	RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION	Oct 17, 2000	Substantially Equivalent	BAUSCH & LOMB, INC.
K002319	PURILENS SALINE SOLUTION	Aug 30, 2000	Substantially Equivalent	PURILENS, INC.
K001539	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	Jul 31, 2000	Substantially Equivalent	BAUSCH & LOMB, INC.
K001214	OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION	Jul 10, 2000	Substantially Equivalent	ALCON UNIVERSAL, LTD.
K000998	OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES	Jun 05, 2000	Substantially Equivalent	OPTISONIC, INC.
K000164	COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION	Jun 02, 2000	Substantially Equivalent	ALLERGAN, INC.
K000247	BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER	Apr 20, 2000	Substantially Equivalent	BAUSCH & LOMB, INC.
K992028	REFRESH CONTACTS LUBRICATING AND REWETTING DROPS	Oct 07, 1999	Substantially Equivalent	ALLERGAN, INC.
K991620	VISINE FOR CONTACTS	Sep 24, 1999	Substantially Equivalent	PFIZER, INC.
K984573	OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP	Sep 16, 1999	Substantially Equivalent	ALCON LABORATORIES
K991125	SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES	Sep 14, 1999	Substantially Equivalent	SAUFLON PHARMACEUTICALS, LTD.
K991403	SOLO-CARE BRAND MULTI-PURPOSE SOLUTION	Jul 16, 1999	Substantially Equivalent	CIBA VISION CORPORATION
K990480	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	May 10, 1999	Substantially Equivalent	ALCON LABORATORIES
K990422	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	Apr 27, 1999	Substantially Equivalent	BAUSCH & LOMB, INC.
K983225	BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER	Mar 29, 1999	Substantially Equivalent	BAUSCH & LOMB, INC.
K990044	LOBOB UNIVERSAL CONTACT LENS CLEANER	Feb 11, 1999	Substantially Equivalent	LOBOB LABORATORIES, INC.
K984575	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Jan 14, 1999	Substantially Equivalent	ALCON LABORATORIES
K984383	ULTRACARE NEUTRALIZING TABLETS	Dec 18, 1998	Substantially Equivalent	ALLERGAN, INC.
K983973	OPTI-ONE MULTI-PURPOSE SOLUTION	Dec 18, 1998	Substantially Equivalent	ALCON LABORATORIES
K983780	MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Dec 18, 1998	Substantially Equivalent	ALCON LABORATORIES
K983150	COMPLETE BRAND LUBRICATING AND REWETTING DROPS	Nov 25, 1998	Substantially Equivalent	ALLERGAN, INC.
K982168	SOLO-CARE BRAND MULTI-PURPOSE SOLUTION	Nov 17, 1998	Substantially Equivalent	CIBA VISION CORPORATION
K982775	BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION	Nov 03, 1998	Substantially Equivalent	BAUSCH & LOMB, INC.
K981168	COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS	Sep 01, 1998	Substantially Equivalent	ALLERGAN, INC.
K981561	LIQUID ENZYME ID 90133	Jul 24, 1998	Substantially Equivalent	ALCON LABORATORIES
K981574	OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION	Jul 06, 1998	Substantially Equivalent	ALCON
K980775	COMPLETE BRAND MULTI-PURPOSE SOLUTION	Jul 06, 1998	Substantially Equivalent	ALLERGAN, INC.
K980591	RENU MULTIPLUS LUBRICATING & REWETTING DROPS	Jun 24, 1998	Substantially Equivalent	BAUSCH & LOMB, INC.
K981151	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392	Jun 22, 1998	Substantially Equivalent	ALCON LABORATORIES
K980147	YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION	Apr 13, 1998	Substantially Equivalent	AUTOMATIC LIQUID PACKAGING, INC.
K980133	BAUSCH & LOMB WETTING AND SOAKING SOLUTION	Mar 11, 1998	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K974723	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	Mar 10, 1998	Substantially Equivalent	BAUSCH & LOMB, INC.
K974625	OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER	Mar 04, 1998	Substantially Equivalent	ALCON LABORATORIES
K974624	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Mar 04, 1998	Substantially Equivalent	ALCON LABORATORIES
K974485	SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION	Feb 24, 1998	Substantially Equivalent	SZABOCSIK AND ASSOC.
K973921	BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION	Jan 12, 1998	Substantially Equivalent	BAUSCH & LOMB, INC.
K973332	ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746	Dec 02, 1997	Substantially Equivalent	ALCON LABORATORIES
K973217	BOSTON LIQUID ENZYMATIC CLEANER	Nov 24, 1997	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K923438	BOSTON CONDITIONING SOLUTION	Dec 28, 1992	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K923437	BOSTON CLEANER II	Oct 28, 1992	Substantially Equivalent	POLYMER TECHNOLOGY CORP.
K914483	WETTING SOLUTION FOR HARD CONTACT LENSES	Feb 05, 1992	Substantially Equivalent	OPTOPICS LABORATORIES CORP.
K890303	OPTI-TEARS(R)	Feb 17, 1989	Substantially Equivalent	ALCON LABORATORIES
K880688	SLC HARD LENS CLEANER	Jun 28, 1988	Substantially Equivalent	OCULAR PHARMACEUTICALS, INC.
K881987	DURACLEAN DAILY CLEANER	Jun 09, 1988	Substantially Equivalent	ALLERGAN OPTICAL
K874364	BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS	Nov 25, 1987	Substantially Equivalent	BAUSCH & LOMB, INC.
K872973	W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION	Oct 15, 1987	Substantially Equivalent	WESLEY JESSEN CORP.
K873548	OPTI-ZYME(R)	Sep 29, 1987	Substantially Equivalent	ALCON LABORATORIES
K872164	RESTORE	Sep 17, 1987	Substantially Equivalent	ANDERSON RESEARCH, INC.
K871714	KESTREL CONTACT LENS CASE	May 26, 1987	Substantially Equivalent	APPLIED LABORATORIES, INC.
K863846	CONTAC CASE	Apr 06, 1987	Substantially Equivalent	S. M. C. MEDI-TECH CORP.
K863346	PROFESSIONAL DISINFECTION SYSTEM (PDS)	Feb 27, 1987	Substantially Equivalent	CIBA VISION CARE
K870278	CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695	Feb 20, 1987	Substantially Equivalent	RYDER INTL. CORP.
K864502	THE CONTACT LENS ASSIST BRUSH	Jan 20, 1987	Substantially Equivalent	YOUNG AND MOORE ENTERPRISES, INC.
K864157	OPTI-BRUSH	Nov 13, 1986	Substantially Equivalent	WILLMAR CONTACT LENS CLINIC
K843511	BAUSCH & LOMB CLEANING PAD	Oct 16, 1986	Substantially Equivalent	BAUSCH & LOMB, INC.
K852386	SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT	Sep 04, 1985	Substantially Equivalent	BARNES-HIND, INC.

FEI Numbers

This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.

1000119582: 5 registrations

1000188353: 16 registrations

1032500: 22 registrations

1317628: 309 registrations

1610287: 54 registrations

1643525: 2 registrations

1719513: 39 registrations

1720129: 4 registrations

1937310: 25 registrations

2011068: 22 registrations

2026940: 5 registrations

3002224304: 1 registration

3002806285: 1 registration

3002808845: 16 registrations

3003062331: 11 registrations

3003093882: 2 registrations

3003306559: 8 registrations

3003485793: 2 registrations

3003515967: 4 registrations

3003595336: 5 registrations

3003598505: 3 registrations

3004178847: 7 registrations

3004270595: 16 registrations

3005010990: 5 registrations

3006140792: 9 registrations

3006195167: 2 registrations

3006974616: 2 registrations

3007392179: 2 registrations

3007490529: 1 registration

3010607087: 7 registrations

3011714173: 4 registrations

3011771819: 41 registrations

3012236936: 46 registrations

3012603529: 2 registrations

3013124682: 34 registrations

3027339426: 2 registrations