Atlas FDA

OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

FDA 510(k) clearance K972454 · decided 1997-08-08

Clearance details

K-number
K972454
Device name
OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb, Inc.
Decision
Substantially Equivalent
Date received
1997-07-01
Decision date
1997-08-08
Days to decision
38 days
Clearance type
Traditional
Product code
LPL
Device class
2
Regulation number
886.5925
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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

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Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K252385)Pegavision Corporation2026-03-13
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Bausch & Lomb SofLens® (polymacon) Contact Lenses (N16895/S107)Bausch & Lomb, Inc.2025-10-24
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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