Atlas FDA

BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS

FDA 510(k) clearance K020927 · decided 2002-05-16

Clearance details

K-number
K020927
Device name
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb
Decision
Substantially Equivalent
Date received
2002-03-21
Decision date
2002-05-16
Days to decision
56 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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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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Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) (K251683)Bruno Vision Care, LLC2025-12-23
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Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) (K244009)Yung Sheng Optical Co., Ltd.2025-09-25
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K251095)Pegavision Corporation2025-09-17
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ADATO SIL-OL 5000 Silicone Oils (P910071/S019)Bausch & Lomb2025-12-22
Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) (P860022/S061)Bausch & Lomb2025-12-16
Boston Orthokeratology (oprifocon A) (P010062/S015)Bausch & Lomb2025-12-16
Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S014)Bausch & Lomb2025-02-20
Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl (P860022/S060)Bausch & Lomb2024-07-18
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S013)Bausch & Lomb2024-07-18
Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL) (P910061/S027)Bausch & Lomb2022-01-19
ADATO Sil-Ol 5000 Silicone Oil (P910071/S018)Bausch & Lomb2021-12-02