ELITA Femtosecond Laser System, ELITA Patient Interface— 510(k) K223566
Substantially EquivalentJohnson & Johnson Surgical Vision, Inc.
FDA 510(k) clearance K223566 for ELITA Femtosecond Laser System, ELITA Patient Interface, Substantially Equivalent on 2023-04-14. Applicant: Johnson & Johnson Surgical Vision, Inc.. Device class: 2.
Clearance details
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Product code
- Code OOE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code OOE
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- K191949 — UNFOLDER Vitan Inserter
- K191933 — COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
Adverse events under product code OOE
product code OOE- Injury
- 1,104
- Malfunction
- 864
- Total
- 1,968
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.