PINPOINTE FOOTLASER— 510(k) K093547

Substantially Equivalent

Pinpointe USA, Inc.

FDA 510(k) clearance K093547 for PINPOINTE FOOTLASER, Substantially Equivalent on 2010-10-15. Applicant: Pinpointe USA, Inc.. Device class: 2.

Clearance details

Applicant: Pinpointe USA, Inc.
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2009-11-17
Decision date: 2010-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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