BPZ02 MULTIPURPOSE SOLUTION— 510(k) K083757
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K083757 for BPZ02 MULTIPURPOSE SOLUTION, Substantially Equivalent on 2009-11-18. Applicant: Bausch & Lomb, Inc.. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb, Inc.
- Product code
- Code LYL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- 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
- 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 LYL
product code LYL- Other
- 1
- Total
- 1
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 →
Recalls naming K083757
K-number listed on FDA's recall record- Z-0126-2015 — Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.
- Z-1554-2014 — Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083757.
Data sourced from openFDA. This site is unofficial and independent of the FDA.