SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS— 510(k) K061157
Substantially EquivalentBausch & Lomb
FDA 510(k) clearance K061157 for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS, Substantially Equivalent on 2006-06-22. Applicant: Bausch & Lomb. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb
- 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
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More clearances from Bausch & Lomb
view allAdverse 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.