XE-LITE— 510(k) K954263

Name: FDA 510(k) clearance K954263
Creator: U.S. Food and Drug Administration
Published: 1995-10-18

Unknown

Ophthalmic Technologies, Inc.

FDA 510(k) clearance K954263 for XE-LITE, Unknown on 1995-10-18. Applicant: Ophthalmic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ophthalmic Technologies, Inc.
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1995-09-12
Decision date: 1995-10-18
Decision: Unknown
Clearance type: Traditional
Location: Downsview, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTD

view all

K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT2013-12-05
K130513 — VOLISTA 400; VOLISTA 6002013-05-08
K123776 — POLARIS 100/2002013-03-08
K111020 — ATRICURE DISSECTOR2011-06-09
K100234 — HM-LAMP II2010-07-08

More clearances from Ophthalmic Technologies, Inc.

view all

K042885 — OCT-OPTHALMOSCOPE2005-01-21
K031391 — HF MODULE WITH TRANSDUCERS2003-06-20
K030770 — OTI SCAN WITH TRANSDUCERS2003-03-27
K024114 — A-SCAN 1002003-01-10
K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM1999-04-04

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.