510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864386Substantially Equivalent

Luxtec Loupes for Surgical Vision

Luxtec Corp., Sturbridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864386 is the FDA 510(k) clearance record for LUXTEC LOUPES FOR SURGICAL VISION, a class I device, cleared for Luxtec Corp. on under FDA product code FSP (Loupe, Diagnostic/Surgical). FDA records list 15 510(k) clearances for Luxtec Corp., from to . As of , FDA records show no recalls naming K864386.

Clearance record

Decision date
Received
(12 days to decision)
Product code
FSP Loupe, Diagnostic/Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Luxtec Corp. P.O. Box 225, Rte. 20/49, Sturbridge MA
Third party review
No

Clearances, product code FSP

Trailing 12 months

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

FDA records show no clearances under product code FSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSP, 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