510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003423Substantially Equivalent

St. Francis Operating Theatre Lamp, Models Olh01-125 and Lc-055

St. Francis Medical Equipment Co., Ltd., Taipei Shien, Taiwan, R.O.C., TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003423 is the FDA 510(k) clearance record for ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055, a class II device, cleared for St. Francis Medical Equipment Co., Ltd. on under FDA product code FTD (Lamp, Surgical). FDA records list one 510(k) clearance for St. Francis Medical Equipment Co., Ltd. As of , FDA records show no recalls naming K003423.

Clearance record

Decision date
Received
(111 days to decision)
Product code
FTD Lamp, Surgical
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
St. Francis Medical Equipment Co., Ltd. P.O. Box 129, Taipei Shien, Taiwan, R.O.C., TW
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