510(k) K093547

PINPOINTE FOOTLASER by Pinpointe USA, Inc. — Product Code PDZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 15, 2010
Date Received: November 17, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Other clearances for product code PDZ

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K221363 — AF Laser (July 20, 2022)
K190034 — REMY Medical Therapy Laser System (May 15, 2019)
K153164 — LunulaLaser (June 3, 2016)
K150138 — Aspen Laser Systems Therapy Laser System (May 8, 2015)
K123014 — LITECURE THERAPY SYSTEM MODEL LTS-1500 (March 29, 2013)
K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (December 12, 2012)
K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)