BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,— 510(k) K131208
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K131208 for BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,, Substantially Equivalent on 2013-09-11. Applicant: Bausch & Lomb, Inc.. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb, Inc.
- Product code
- 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
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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
- K122575 — BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
- K113852 — BAUSCH & LOMB IOL INJECTOR
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.