Cleared Traditional

K954263 - XE-LITE
(FDA 510(k) Clearance)

K954263 · Ophthalmic Technologies, Inc. · General & Plastic Surgery device

Oct 1995

Decision

36d

Days

Class 2

Risk

K954263 is an FDA 510(k) clearance for the XE-LITE. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).

Submitted by Ophthalmic Technologies, Inc. (Downsview, Ontario, CA). The FDA issued a Cleared decision on October 18, 1995, 36 days after receiving the submission on September 12, 1995.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K954263 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received	September 12, 1995
Decision Date	October 18, 1995
Days to Decision	36 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF