Bausch + Lomb Sensitive Eyes Plus Saline Solution— 510(k) K170483
Substantially EquivalentBausch & Lomb, Incorporated
FDA 510(k) clearance K170483 for Bausch + Lomb Sensitive Eyes Plus Saline Solution, Substantially Equivalent on 2017-04-11. Applicant: Bausch & Lomb, Incorporated. Device class: 2.
Clearance details
- Applicant
- Bausch & Lomb, Incorporated
- Product code
- Code LPN
- 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
Recent devices under product code LPN
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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
- K211786 — Independent Corneal Viewing Chamber (IVC-21)
- K210975 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
Adverse events under product code LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
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.