Atlas FDA

RENU MULTIPLUS MULTI-PURPOSE SOLUTION

FDA 510(k) clearance K990422 · decided 1999-04-27

Clearance details

K-number
K990422
Device name
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
Applicant
Bausch & Lomb, Inc.
Decision
Substantially Equivalent
Date received
1999-02-11
Decision date
1999-04-27
Days to decision
75 days
Clearance type
Traditional
Product code
LPN
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

No recalls on record reference this clearance.

PMA approvals by this applicant

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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