XE-LITE— 510(k) K954263

Unknown

Ophthalmic Technologies, Inc.

FDA 510(k) clearance K954263 for XE-LITE, Unknown on 1995-10-18. Applicant: Ophthalmic Technologies, Inc..

Clearance details

Applicant: Ophthalmic Technologies, Inc.
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 1995-09-12
Decision date: 1995-10-18
Decision: Unknown
Clearance type: Traditional
Location: Downsview, Ontario, CA

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.