510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954263Unknown

Xe-Lite

Ophthalmic Technologies, Inc., Downsview, Ontario, CA / Traditional, Unknown
FDA source (opens on fda.gov)

K954263 is the FDA 510(k) clearance record for XE-LITE, a class II device, cleared for Ophthalmic Technologies, Inc. on under FDA product code FTD (Lamp, Surgical). FDA records list 9 510(k) clearances for Ophthalmic Technologies, Inc., from to . As of , FDA records show no recalls naming K954263.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FTD Lamp, Surgical
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ophthalmic Technologies, Inc. 37 Kodiak Crescent,, Downsview, Ontario, CA
510(k) summary
Summary
Third party review
No

Clearances, product code FTD

Trailing 12 months

FDA records hold no clearances under product code FTD in the trailing twelve months.

FDA records show no clearances under product code FTD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FTD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260