LUXTEC LOUPES FOR SURGICAL VISION— 510(k) K864386

Substantially Equivalent

Luxtec Corp.

FDA 510(k) clearance K864386 for LUXTEC LOUPES FOR SURGICAL VISION, Substantially Equivalent on 1986-11-17. Applicant: Luxtec Corp.. Device class: 1.

Clearance details

Applicant: Luxtec Corp.
Product code: Code FSP
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-11-05
Decision date: 1986-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSP

K895248 — IMS5000 ILLUMINATED LOUPES1989-09-15
K891895 — SURGICAL LOUPES1989-04-12
K861749 — 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE1986-05-23

More clearances from Luxtec Corp.

K973193 — LUXSCOPE1997-11-21
K970642 — TENOSCOPE1997-05-21
K970562 — TENOSNARE1997-05-14
K950960 — REDDY ILLUMINATOR1995-09-08
K890716 — LUXTEC ACO SERIES 4000 LIGHT SOURCE1989-04-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.