Atlas FDA

BPZ02 MULTIPURPOSE SOLUTION

FDA 510(k) clearance K083757 · decided 2009-11-18

Clearance details

K-number
K083757
Device name
BPZ02 MULTIPURPOSE SOLUTION
Applicant
Bausch & Lomb, Inc.
Decision
Substantially Equivalent
Date received
2008-12-17
Decision date
2009-11-18
Days to decision
336 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

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Recalls involving this device

RecordFirmDate
Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by W recall (Z-0126-2015)Bausch & Lomb Inc- Greenville Solutions Plant2014-10-24
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile. recall (Z-1554-2014)Bausch & Lomb Inc- Greenville Solutions Plant2014-05-06

PMA approvals by this applicant

RecordFirmDate
Bausch & Lomb SofLens® (polymacon) Contact Lenses (N16895/S107)Bausch & Lomb, Inc.2025-10-24
Akreos Posterior Chamber Intraocular Lens (P060022/S037)Bausch & Lomb, Inc.2025-09-30
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S003)Bausch & Lomb, Inc.2025-07-30
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036)Bausch & Lomb, Inc.2025-07-22
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035)Bausch & Lomb, Inc.2025-07-09
enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060)Bausch & Lomb, Inc.2025-06-18
enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059)Bausch & Lomb, Inc.2025-05-30
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004)Bausch & Lomb, Inc.2025-05-30