LUTEX HEADLIGHT SYSTEMS— 510(k) K864380

Substantially Equivalent

Luxtec Corp.

FDA 510(k) clearance K864380 for LUTEX HEADLIGHT SYSTEMS, Substantially Equivalent on 1986-11-19. Applicant: Luxtec Corp.. Device class: 2.

Clearance details

Applicant: Luxtec Corp.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1986-11-05
Decision date: 1986-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Luxtec Corp.

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