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510(k) K222541

Device
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Applicant
Bausch & Lomb, Incorporated
510(k) number
K222541
Product code
LPN
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-06
Date received
2022-08-22
Regulation
886.5928
Classification name
Accessories, Soft Lens Products
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Melissa Thomas
Address
1400 N. Goodman St. Rochester NY US 14609 14609

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC2021-05-26
K193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.2020-05-26
K200747PuriLens Plus Preservative Free SalineThe Lifestyle Company, Inc.2020-05-15
K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd.2020-03-02
K190674REFRESH RELIEVA For CONTACTSAllergan, Inc.2019-08-08
K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc.2019-07-31
K170483Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated2017-04-11
K161819NNR06 Multi-Purpose SolutionBausch & Lomb, Incorporated2016-11-25
K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.2016-10-19
K161622LensGiene Sterile Saline SolutionOptics Laboratory, Inc.2016-08-11
K151768Menicon Saline Rinse SolutionMenicon Co, Ltd.2015-08-28
K142284CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDEAlcon Laboratories, Inc.2015-01-26
K132216BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTIONBausch & Lomb, Incorporated2013-09-09