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510(k) K093547

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

K093547 is an FDA 510(k) premarket notification submitted by Pinpointe USA, Inc. for the device "PINPOINTE FOOTLASER". The FDA issued a decision of Substantially Equivalent on October 15, 2010. The device falls under product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis), a Class II device regulated under 21 CFR 878.4810.

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.).

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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)

FDA data resources