Atlas FDA

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

FDA 510(k) clearance K061157 · decided 2006-06-22

Clearance details

K-number
K061157
Device name
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb
Decision
Substantially Equivalent
Date received
2006-04-26
Decision date
2006-06-22
Days to decision
57 days
Clearance type
Special
Product code
MVN
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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Similar devices under this product code

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

RecordFirmDate
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (K261812)HOYA Lamphun , Ltd.2026-07-07
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202448)Alcon Laboratories, Inc.2020-09-22
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (K202036)Alcon Laboratories, Inc.2020-08-21
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear (K150630)Yung Sheng Optical Co., Ltd.2015-06-15
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (K143190)Yung Sheng Optical Co., Ltd.2015-01-16
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER (K130331)Sauflon Pharmaceuticals, Ltd.2013-07-26
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (K112192)Bausch & Lomb, Inc.2011-10-25
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (K080632)Clearlab SG Pte, Ltd.2008-10-15
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (K080755)Bausch & Lomb, Inc.2008-06-10
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K073060)Innova Vision, Inc.2007-11-29
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (K061948)CooperVision, Inc.2006-11-22
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES (K052832)Sauflon Pharmaceuticals, Ltd.2006-05-15

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