Home / 510(k) Clearances / K121508

510(k) K121508

LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N by Fotona D.D. — Product Code PDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2012
Date Received
May 21, 2012
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 by Fotona D.D.

  • K241785 — StarFormer (M008-3T) (March 27, 2025)
  • K242202 — LightWalker Laser System Family (August 23, 2024)
  • K234061 — StarFormer (July 1, 2024)
  • K221274 — StarFormer, TightWave (September 29, 2023)
  • K223540 — AvalancheLase Family (January 19, 2023)
  • K221712 — Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (October 12, 2022)
  • K213267 — Dynamis Pro Family (September 8, 2022)
  • K202991 — Fotona XPulse Pro Laser Platform (June 22, 2021)
  • K202985 — LightWalker Laser System Family (March 19, 2021)
  • K202172 — StarWalker (November 19, 2020)

Other clearances for product code PDZ

  • K253960 — Medicell Mycosis Laser (MCML24004) (March 9, 2026)
  • K241116 — Onycho Laser V (July 22, 2024)
  • K211265 — TFX-LT2000 Therapy Light (November 17, 2022)
  • 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)
  • K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)
  • K120938 — THE PL-1064 LASER SYSTEM (September 24, 2012)