AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28— 510(k) K063694
Substantially EquivalentBausch & Lomb, Inc.
FDA 510(k) clearance K063694 for AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28, Substantially Equivalent on 2007-03-07. Applicant: Bausch & Lomb, Inc.. Device class: 1.
Clearance details
- Applicant
- Bausch & Lomb, Inc.
- Product code
- Code KYB
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Dimas, CA, US
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- K122575 — BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
Adverse events under product code KYB
product code KYB- Injury
- 218
- Malfunction
- 1,989
- Other
- 1
- Total
- 2,208
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.