Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens— 510(k) K143632
Substantially EquivalentBausch & Lomb, Incorporated
FDA 510(k) clearance K143632 for Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens, Substantially Equivalent on 2015-02-13. Applicant: Bausch & Lomb, Incorporated. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb, Incorporated
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code LPL
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- K262941 — Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- K262495 — Miru 1day UpSide (midafilcon A)
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More clearances from Bausch & Lomb, Incorporated
view all- K242389 — EyeGility Inserter for Preloaded enVista IOLs
- K230954 — Samfilcon B Custom Contact Lens
- K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
- K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
- K211786 — Independent Corneal Viewing Chamber (IVC-21)
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.