ELITA Femtosecond Laser System, ELITA Patient Interface
Summary
Johnson & Johnson Surgical Vision, Inc. received 510(k) clearance for ELITA Femtosecond Laser System, ELITA Patient Interface, a OOE device. Cleared on 2023-04-14.
Details
Source
510(k) Clearance
External ID
K223566
Action Date
2023-04-14
Status
Traditional
Category
device
Product Code
OOE
Product Description
ELITA Femtosecond Laser System, ELITA Patient Interface. Product code: OOE.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Johnson & Johnson Surgical Vision, Inc. has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Johnson & Johnson Surgical Vision, Inc. have FDA actions?
Johnson & Johnson Surgical Vision, Inc. has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223566" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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