NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS— 510(k) K112192
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K112192 for NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS, Substantially Equivalent on 2011-10-25. Applicant: Bausch & Lomb, Inc.. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb, Inc.
- Product code
- Code MVN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Recent devices under product code MVN
view all- K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens +2 more
- K202448 — DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- K202036 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
- K150630 — 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
- K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
More clearances from Bausch & Lomb, Inc.
view all- K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded
- K173480 — Crystalsert Lens Delivery System
- K151102 — Bausch + Lomb Injector System
- K131208 — BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
- K122575 — BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
Adverse events under product code MVN
product code MVN- Injury
- 149
- Total
- 149
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.