Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact Lens
FDA 510(k) K112192 · Bausch & Lomb, Inc.
510(k) numberK112192
Submission
- Device name
- Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact Lens
- Applicant
- Bausch & Lomb, Inc.
Rochester, NY, US - Received
- July 29, 2011
- Decision date
- October 25, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVN – Lens, Contact, (Disposable)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code MVN
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|---|---|---|---|
| K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…MVN · Special | HOYA Lamphun , Ltd. | 07/07/2026SE |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalMVN · Special | Alcon Laboratories, Inc. | 09/22/2020SE |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…MVN · Special | Alcon Laboratories, Inc. | 08/21/2020SE |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…MVN · Traditional | Yung Sheng Optical Co., Ltd. | 06/15/2015SE |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensMVN · Traditional | Yung Sheng Optical Co., Ltd. | 01/16/2015SE |
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…MVN · Traditional | Sauflon Pharmaceuticals, Ltd. | 07/26/2013SE |
| K080632 | CLEAR1-DAY Hioxifilcon Daily Disposable Soft Contact LensMVN · Traditional | Clearlab SG Pte, Ltd. | 10/15/2008SE |
| K080755 | Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted Contact LensMVN · Traditional | Bausch & Lomb, Inc. | 06/10/2008SE |
| K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearMVN · Special | Innova Vision, Inc. | 11/29/2007SE |
| K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensMVN · Traditional | CooperVision, Inc. | 11/22/2006SE |
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| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…LPL · Traditional | 03/08/2023SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | 12/06/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | 05/28/2021SE |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaLPL · Traditional | 05/24/2021SE |
| K200416 | Boston One Step Liquid Enzymatic CleanerMRC · Traditional | 09/23/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | 10/04/2019SE |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…HQD · Traditional | 02/12/2019SE |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL · Traditional | 11/30/2018SE |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…MRC · Traditional | 08/10/2018SE |
Questions and answers
When was Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact Lens cleared by the FDA?
Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact Lens (K112192) received a 510(k) decision of Substantially Equivalent on October 25, 2011, 88 days after the submission was received.
What is the product code of K112192?
The FDA product code is MVN – Lens, Contact, (Disposable), a Class II (moderate risk) device regulated under 21 CFR 886.5925.