Home / 510(k) Clearances / K111483

510(k) K111483

JOULE CLEARSENSE LASER SYSTEM by Sciton, Inc — Product Code PDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2011
Date Received
May 31, 2011
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 Sciton, Inc

  • K251077 — JOULE 1064nm System and Accessories (December 19, 2025)
  • K222958 — mJOULE RF System and Accessories (April 23, 2024)
  • K213761 — Joule diVa System (July 19, 2022)
  • K213350 — mJOULE System and Accessories (April 15, 2022)
  • K182173 — Joule System (March 6, 2019)
  • K180508 — JOULE SYSTEM (May 18, 2018)
  • K173285 — JOULE SYSTEM (January 29, 2018)
  • K122567 — JOULE 810/940/980 MULTI-PLATFORM SYSTEM (June 19, 2013)
  • K101916 — JOULE MULTI-PLATFORM SYSTEM (March 18, 2011)
  • K081352 — PROFILE MULTI-PLATFORM SYSTEM (October 23, 2008)

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)
  • K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (December 12, 2012)
  • K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)